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Instructor : David R Dills
Product Id : 30384PACK

Overview: This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.

Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests. Consistent with increased public attention to physician-industry ties and connections, the tone of the guidance suggests or infers that clinical trial sponsors should expect a more rigorous review by FDA of these financial arrangements.

This Webinar highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA. The financial disclosure regulations in 21 CFR 54 are designed to help uncover potential investigatory bias that may arise due to financial ties between the investigator and the clinical trial sponsor.

This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the "draft" offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDA's current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.

Areas Covered in the Session:
  • Review proposed changes to the 2011 released draft guidance
  • Clarification on definition of sponsor
  • Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application
  • Learn how to submit financial disclosure information to FDA
  • Why FDA is expounding on due diligence and its significance
  • Timing of data collection and purpose
  • Understand how financial information should be disclosed to FDA
  • Update regarding financial disclosure questionnaires
  • Time period covered by regulations
  • Clarification on covered clinical study
  • Factors for FDA review of disclosed financial interests

Who Will Benefit:
The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA's draft guidance on financial disclosure by clinical investigators, including:
  • Regulatory Affairs
  • Clinical Affairs
  • Investigators
  • Quality and Compliance
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : Robert J. Russell
Product Id : 30384PACK

Overview: This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers.The root of many of the problems lies in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files) which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

Areas Covered In the Session:
  • What are DMFs?
    • Types of DMFs (Types II, III, IV and V)
  • The rationale and preparation process for DMFs
    • Why DMFs are important to you and your company
    • How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
    • Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
    • What not to include
  • DMF Preparation: What you need and why you need it
    • The essential components of all DMFs, including:
    • The relationship between DMFs and cGMPs
    • Tactics for avoiding the most common DMF-related errors
    • Tactics for dealing with unique or novel situations/unfavorable reviews
  • FDA Review: How FDA reviews DMFs and why.
    • What you should expect throughout the DMF preparation and filing process
    • How to communicate and work with FDA to ensure success
  • Components Associated with a DMF:
    • DMF vs. Application
    • Acknowledgement Letter
    • Letter of Authorization
    • Changes to a DMF
    • Annual updates
    • Obligations of a DMF holder
    • Transmissions - transmittal letter
    • Deficiency letter
    • Auditing Vendor
    • Inside tips
    • Changes to DMF system in last 10 years
    • Binder specifications and cover sample
  • Japan DMFs
  • European DMFs
  • Canadian DMFs
  • Change control and maintenance: Why accurately maintaining your DMFs is important
    • DMFs as "living" documents. DMF updates and amendments
    • Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
    • What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

Who will benefit:The course will be especially useful for personnel responsible for:
  • Manufacturing
  • Regulatory Affairs
  • Project Managers
  • Global Supply Chain
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials
  • General Management


Instructor : David R Dills
Product Id : 30384PACK

Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.

FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule).The Proposed Rule contains four types of proposed changes to FDA's device establishment registration and device listing regulations. For example, Proposed Rule would amend FDA’s current regulations to make them consistent with provisions of the 2007 FDAAA pertaining to electronic device establishment registration and listing, many of which FDA has already implemented. Second, the Proposed Rule would require establishments to provide certain information that FDA currently requests when the establishment registers or lists a device, but is not mandatory.

Proposed Rule would also amend the regulations to facilitate FDA’s collection of information from foreign establishments regarding their devices that are imported into the U.S. as required by the 2002 Bioterrorism Act and other proposed changes to be addressed. The Proposed Rule, if finalized, would require establishments to provide additional or different information than specified in the current regulations, but which FDA now requests via FURLS. This Webinar will provide latest update as well as a "refresh" overview on how to register your device company and list your device(s) correctly and meeting requirements and expectation regardless of the outcome of the Proposed Rule.

Areas Covered In the Seminar:
  • When and how to register and list
  • Review the four proposed changes to FDA's device establishment registration and device listing regulations
  • Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices
  • Other proposed Amendments that would change current device establishment registration and listing requirements
  • Replacement of the current regulations regarding updating device listing information outside the required update periods
  • Clarification of who must provide establishments’ registration numbers

Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms, importers and those who need to register their device firms and list their device(s). The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the establishment registration and listing process from start to finish, including:
  • Regulatory Affairs
  • Quality and Compliance
  • Marketing & Sales
  • Importers
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services/Operations
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : Robert J. Russell
Product Id : 30384PACK

Overview: New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU.

The legal framework for pharmacovigilance on Medicinal Products for Human Use has now been updated, through an amended EU Regulation (No 1235/2010) and Directive (2010/84/EC).

Why should you attend: This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012. The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module, of which the first seven Modules have been disclosed for public consultation. This Course will describe the Regulatory Updates, Guidance Updates and thoughts on how some Member States’ Competent Authorities will proceed with implementation.

These regulatory changes will also impact the EU Clinical Trial Directive and expectations of sponsors in the protection of patients and public health, before, during and after a clinical study.

Learning Objectives:
Upon completion of this course, attendees will have a thorough knowledge of the updated framework surrounding Good Pharamcovigilance Practices (GVP). This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation. The content of this course is designed to simplify the understanding of the new requirements and to provide attendees with the latest information on what the European Commission believes is a significant area of improvement in the region.

Areas Covered in the Session:
  • Overview of EU Regulatory structure
  • EU Pharmacovigilance : Why make changes now?
  • New definitions for the updated directive and regulation
  • Organization of PV Modules
  • Update to the EU Pharmacovigilance legislation
    • How the new legislation will better protect patient safety
    • How the new legislation will affect Marketing Authorization Holders
    • How the new legislation will affect Sponsors of Clinical Studies
    • Adverse Drug Reaction Reporting
      • Periodic Safety Update Reports
      • Post-Authorization Safety Studies
  • Eudravigilance Database
  • Changes to labeling
  • The Pharmacovigilance Risk Assessment Committee
  • Implementation timing & expectations

Who Will Benefit: This course will be beneficial to:
  • Senior Management
  • Project Managers
  • Clinical Trial Heads
  • PV Reporting
  • Medical Writers
  • Project Managers
  • CRAs and CRCs
  • QA / Compliance personnel
  • Investigators
  • Clinical Research Scientists
  • QA / QC Auditors and Staff
  • Consultants


Instructor : Robert Kunka
Product Id : 30384PACK

Overview: Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.

The FDA and other regulatory agencies produce numerous guidances on specific topics that are very helpful. However, there are other issues that can interfere with the developmental process. This presentation will identify these potential problems and recommend how to address them. The areas covered will include: stages of drug development, company teams for developing a drug, relevant structure of the FDA, process of contacting the FDA, important milestone meetings and documents, preparation for meetings, resolve potential issues, and logistics.

This webinar should be "required reading" for those who want to be a member of a drug project team and any of the sub-teams. The first step in the drug development approval process is knowing what needs to be done. When the company starts interacting with the FDA, knowing the steps that are required will likely give the FDA some initial confidence of the proposed plan.

Areas Covered in the Session:
  • Organization of the FDA
  • Stages in drug development
  • Important meetings with the FDA
  • Logistics of regulatory meetings
  • Content of protocols and clinical reports
  • Outline of IND and NDA application

Who Will Benefit:
  • Formulation Managers and Scientists
  • Project Managers
  • Pharmacokineticists
  • Clinical Research Scientists (CRS) and Associates (CRA)



Instructor : David R Dills
Product Id : 30384PACK

Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems.

This session provides an overview on identifying recommended practices to improve, streamline, refine, retool…and develop, deploy and maintain a viable and sustainable CAPA system. Learn that a well written policy and procedure on setting up and maintaining your system is just the first part of the process…now you need to monitor your system because CAPA is your immune system and will determine how healthy or unhealthy or business site is. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.

Areas Covered in the Session:
  • How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria
  • How to facilitate a product complaint investigation as part of your CAPA program
  • What is a closed-loop investigation…cradle to grave approach
  • How to conduct an investigation using a well-written CAPA policy and procedure
  • Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions
  • Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice
  • Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions
  • Develop and deploy escalation rules and criteria to facilitate decision-making process
  • Understand what it takes to conduct a “quality” investigation to ascertain the root cause
  • Review and discuss recent CAPA red flags and FDA enforcement actions

Who Will Benefit:This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner. The employees who will benefit include:
  • All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
  • QA/QC/CAPA Coordinators/CAPA Specialists
  • Regulatory Affairs and Compliance
  • Engineering/Technical Services/Operations
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : Anne Tomalin
Product Id : 30384PACK

Overview: Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.

Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability study ongoing in Denmark and new legislation in France using public policy to drive use of biosimilars. We will address upcoming patent losses, and what is known about current development of new biosimilars.

Why should you Attend: Understanding this fast developing area is critical. How will approvals be handled. Will indications be able to be bridged from a clinical study in one therapeutic area to another. Will interchangeability be recognized? How are some products / companies being successful? These are all questions in this complex landscape. We will address the current thinking on each and provide an update in terms of what is being done by whom in terms of development in this area.

Areas Covered in the Session:
  • Biosimilar legislation in the US
  • Purple Book
  • Marketing applications filed using the biosimilar route or other routes
  • Interchangeability requirements
  • Status of subsequent entry biologics in Canada
  • Review of two products that have been successful in Canada by two different routes
  • Existing guidelines in Europe
  • Review of approvals in Europe
  • Interchangeability for infliximab in Denmark
  • Public policy driving biosimilars in France
  • Ongoing development work on biosimilars worldwide

Who Will Benefit:
  • CEO
  • Marketing director
  • New Business Director
  • Regulatory Affairs Director
  • Research Director
  • Clinical Director
  • Nonclinical Director

Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies. Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005). Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.

Anne founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years. Prior to Roche, Anne was employed for three years by Wyeth Ltd. Anne has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association of Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA). In Canada, Anne has also chaired the Manitoba, Saskatchewan and Ontario Committees for the Pharmaceutical Manufacturers Association of Canada (PMAC), now Rx&D, and she has worked with the Nova Scotia Department of Health to revamp their drug formulary. Anne is also engaged in teaching several regulatory courses to industry, including inhouse training courses for several large companies.

Instructor : Jonathan M. Lewis
Product Id : 30384PACK

Overview: Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program?

Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Why should you Attend: 25% of overall facility costs are associated with validation activities. Don't let the money you spend become a wasteful effort. Companies face many common issues or confusions that arise while creating a validation program such as:
  • Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ).
  • What is the difference between a validation master plan and a set of validation SOPs.
  • How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program.

Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed webinar designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Areas Covered in the Session:
  • Define a sustainable structure of a firm's validation program
  • Understand how change control and other quality programs feed into the validation program
  • Define minimal recommended tests and verifications for equipment qualification
  • Discuss what FDA is really looking for in process validation
  • Specify the deliverables associated with software validation
  • Common pitfalls to avoid when executing validation protocols
  • How to estimate costs and time associated with validation
  • How to respond to customer and regulatory audit observations associated with validation
  • Define a sustainable structure of a firm's validation program
  • Understand how change control and other quality programs feed into the validation program
  • Define minimal recommended tests and verifications for equipment qualification

Who Will Benefit:
  • Internal Auditors
  • Senior Management
  • Compliance Officers
  • QA Managers
  • QC Managers
  • Purchasing Managers
  • Validation Engineers and Managers
  • Facilities and Engineering Department Staff


Instructor : Anne Tomalin
Product Id : 30384PACK

Overview: This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.

Some guidelines have been developed and others are in the process of being developed. In some jurisdictions clinical trials are differentiated from observational studies. Conducting such studies retrospectively or prospectively can have a different requirement from a regulatory perspective. The same study done in different jurisdictions will follow different regulatory pathways. Working through this confusing environment is very difficult.

Areas Covered in the Session:

  • What observational studies are and when they are used, including actual examples of such studies conducted in the United States, Canada and Europe.
  • When retrospective observational studies are useful and when prospective observational studies are done.
  • The difference between observational studies and registries.
  • Existing guidelines on such studies in the various jurisdictions.
  • Regulatory requirements to conduct such studies in a jurisdiction.
  • Multi-center studies conducted across jurisdictions.
  • When payer databases are useful and when other approaches are used.
  • Reporting adverse events in observational studies.

Who Will Benefit:

  • Director of Regulatory Affairs
  • Manager of Regulatory Affairs
  • Director of Clinical Affairs
  • Manager of Clinical Affairs
  • Coordinator of Medical Affairs
  • Medical Director
  • Director of Marketing
  • Marketing Manager
  • Reimbursement Director
  • Reimbursement Manager
  • Director of Epidemiology
  • Manager of Epidemiology
  • General Manager

Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies. Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005). Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.

Anne founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years. Prior to Roche, Anne was employed for three years by Wyeth Ltd. Anne has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association of Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA). In Canada, Anne has also chaired the Manitoba, Saskatchewan and Ontario Committees for the Pharmaceutical Manufacturers Association of Canada (PMAC), now Rx&D, and she has worked with the Nova Scotia Department of Health to revamp their drug formulary. Anne is also engaged in teaching several regulatory courses to industry, including inhouse training courses for several large companies.

Instructor : John N. Zorich
Product Id : 30384PACK

Overview: The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality. Spreadsheets are shown as examples of how to implement the methods described in the webinar. A final discussion is provided on how to introduce the methods into a company.

Why should you attend: All manufacturing and development companies perform testing and/or inspections that involve concluding whether or not a product or lot is acceptable vs. design or QC specifications. Such test/inspections may occur during design verification/validation or during incoming or final QC. The most informative method for analyzing the data that results from such activities is the calculation of the product's or lot's "reliability" at a chosen "confidence" level (where "reliability" means "in-specification"). Such a method produces information that is more valuable than simply that the given product or lot "passed" (as is the case when "AQL Attribute Sampling Plans" are used) or a % in-specification statement without any corresponding confidence statement (as is the case with AQL Variables Sampling Plans and with Process Capability calculations).

The output of a "Confidence/Reliability" calculation is a definitive statement that the given product or lot has a specific % in-specification, which conclusion we can state with a specific level of confidence (e.g., 95% confidence of 99% reliability, or 90% confident of 93% reliability").

Areas Covered in the Session:
  • Regulatory Requirements
  • Vocabulary and Concepts
  • Attribute Data
  • Normal Data
  • Normal Probability Plotting
  • Non-Normal Data that can be normalized
  • Reliability Plotting (for data that cannot be normalized)
  • Implementation Recommendations

Who Will Benefit:
  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer


Instructor : David R Dills
Product Id : 30384PACK

Overview: There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Objectives:
  • Know the differences between the Traditional, Special and Abbreviated submissions
  • Understand Substantial Equivalence and how it is applied
  • Who is required to submit the application to FDA
  • Where to submit the 510(k) and what to expect with the review and approval process
  • When it is and is not required if you are a device company
  • Exemptions to the submission process and special considerations
  • How to locate a "predicate" device and go through the content and format of the 510(k)
  • Understand the De Novo process and the expectations for possibly marketing a low risk device
  • Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention
Detailed Agenda:

Introduction and Regulatory Background
  • There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission.
  • Current trends with the 510(k) process.
The Process
  • Who is Required to Submit a 510(k)
  • When a 510(k) is Not Required
  • When a 510(k) is Required
  • Locating and justifying the Predicate
  • Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
  • How to Prepare Submissions
  • 510(k) Submission Methods
  • List of forms associated with Premarket Notification 510(k) submissions
  • Deciding When to Submit a 510(k) for a Change to an Existing Device
  • What happens if FDA requires additional information and data and your responsibilities
Interactive Q&A, Wrap-Up and Adjourn

  • Q&A with all attendees
  • Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry
  • Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc.
  • 510(k) Frequently Asked Questions
  • Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session

Who Will Benefit:
  • This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R&D, development, quality assurance and quality control, production, operations, engineering, compliance, and regulatory affairs and all levels of management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process.

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : John N. Zorich
Product Id : 30384PACK

Overview: The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias. The webinar ends with an explanation of how to combine all relevant uncertainty information into an "Uncertainty Budget" that helps determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications"). Spreadsheets are used to demonstrate how to perform the methods described during the webinar.

Why should you Attend: All manufacturing and development companies perform testing and/or inspection that involves measurements of products, components, and/or raw materials. The output of those measurements is compared to design or QC specifications, to determine whether or not the measurements "pass" those specifications.

However, all measurement processes have some inherent variability; that is, a given measurement will likely not be exactly equal to the true value, because of variation from a number of different sources. Some of those sources are: person to person, equipment to equipment, time to time, and calibration to calibration. How much trust to place in a given measurement can be quantified by determining the magnitude of each of those sources; in effect, the larger the uncertainty of the measurement (i.e., the greater the measurement variation, in comparison to the size of the design or QC specification interval), the lower the trust that should be placed in a given measurement. If the measurement uncertainty can be quantified, it can be applied to reduce the width of the design/QC specifications, so that the resulting "guard banded" specifications can be used without concern for measurement variation.

Areas Covered in the Session:
  • Fundamental Vocabulary & Concepts
  • Gage R&R (ANOVA method)
  • Gage Correlation
  • Gage Linearity
  • Gage Bias
  • Uncertainty Budgets and Guard-banded Specifications

Who Will Benefit:
  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer


Instructor : Thomas E. Colonna
Product Id : 30384PACK

Overview: In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.

In addition, FDA regulation and enforcement discretion relating to IVDs developed by clinical laboratories for internal use, key reagents required for developing such tests, instruments needed to analyze IVDs, and sample collection kits used to obtain specimens will be addressed.

Areas Covered in the Session:
  • Definition of IVD
  • FDA Regulatory Pathways
  • QSR/CLIA Compliance
  • Product Labeling

Who Will Benefit:
  • CEOs
  • VPs
  • Compliance officers
  • Clinical affairs
  • Regulatory affairs
  • Quality assurance
  • R&D
  • CROs
  • Consultants
  • Contractors/subcontractors


Instructor : Louis Angelucci
Product Id : 30384PACK

Overview: Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.

Why should you Attend: The reason for attending would be to gain a perspective on what the expectations of a quality system are as they applies to validation and the requirements of regulations for the pharmaceutical and medical device industries.

Areas Covered in the Session:
  • Regulatory expectation regarding quality systems
  • How to establish quality systems
  • Quality systems fundamental
  • FDA definitions
  • Fitting within the FDA puzzle
  • How to maintain and operate within a quality environment

Who Will Benefit:
  • QA specialist
  • Quality Systems Specialist
  • Managers
  • Operators


Instructor : David R Dills
Product Id : 30384PACK

Overview: FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.

FDA has the right to see certain elements of your supplier qualification/purchasing controls related proof, i.e., the documentation. Learn why and how to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Understand why you need to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. Document this evaluation or assessment and define the type and extent of control to be exercised based on the evaluation results. You need to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements. Identify the key elements of a robust, sustainable and successful supplier qualification program. The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. The process defines the elements associated with a supplier's processes that are critical to quality. It also defines how conformance to manufacturer requirements will be monitored and verified.

Areas Covered in the Session:
  • Learn the pre-selection, selection and assessment process through the use of various tools
  • Methods, techniques and strategies that work and are proven with supplier relations and qualification
  • Learn how to apply risk-based approaches and why and how to "rank" suppliers
  • Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments
  • What to measure and how to measure supplier performance and assign classifications or levels
  • Selection and qualification of suppliers by audits and performance analysis are part of your quality system
  • Approved Supplier List and areas to be targeted during the assessment or evaluation
  • Learn the elements of the SOP and the assessment of supplier capabilities

Who Will Benefit:
  • All levels of Management and personnel from all departments who desire to learn how this process works
  • QA/QC/Compliance/Regulatory Affairs
  • Engineering/R&D/Technical Services
  • Purchasing/Procurement/Sourcing
  • Consultants
  • Operations/Manufacturing/Validation

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : Betty Lane
Product Id : 30384PACK

Overview: In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.

We will also cover where else in your quality management system root-cause analysis can be used. Learn how Root cause analysis can be used in process control. We will describe and give examples of some of the techniques for doing and effective root cause analysis. You will learn about various techniques that are available so you can choose the one or ones that fit your situation.

Why should you Attend: Is your Corrective action system effective or do the same or similar problems keep occurring? If so you may not be doing root cause analysis in sufficient depth. Corrective and Preventive actions (CAPA) are key to an effective quality management system. Corrective and Preventive Action is one area where the FDA continually finds problems in quality systems. And if you do not do an effective Root Cause you will not have a good corrective action system and will find that problems will reoccur, and are likely to lead to increasingly more serious problems.

Areas Covered in the Session:
  • What is Root Cause
  • The difference between Correction, Corrective Action and Preventive Action
  • Why Root Cause Analysis is important
  • Where Root cause Analysis is valuable
    • Corrective and Preventive Action
    • Risk Management
    • Process Control
  • Several techniques for doing Root Cause Analysis
  • Relationship between Root Cause and Risk Management
  • Looking other places in the QMS where Root Cause Analysis is valuable

Who Will Benefit:
  • Quality Managers and Directors
  • Quality Engineers
  • Manufacturing Engineers
  • Internal auditors
  • Quality specialists
  • Quality Associates
  • Operations and Manufacturing Managers
  • Process Engineers

Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.

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