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Instructor : Steven S. Kuwahara
Product Id : 30385PACK

Overview: When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.

Areas Covered in the Session:
  • GLP requirements that are assigned to a test facility and cannot be transferred back to a client.
  • Responsibilities of the sponsor or client.
  • The quality agreement and what it should contain to protect the interests of both client and contractor.
  • Auditing the contractor for compliance with the GLP ot GMP.
  • What is ISO 17425 and what is its effect on contract laboratories and their clients?

Who Will Benefit:
  • Employees who must deal with contract laboratories
  • Employees of contract laboratories who must deal with clients.
  • Quality assurance personnel
  • Regulatory Affairs personnel.
  • Project managers who must select contract testing laboratories.
  • Auditors who must deal with contract testing laboratories.


Instructor : Steven S. Kuwahara
Product Id : 30385PACK

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Areas Covered in the Session:
  • GMP regulations that apply to analytical laboratories.
  • Reviewing documentation
  • Advance preparation for the audit
  • Auditing styles and structures
  • Equipment and laboratory instrument qualification.
  • What to look for while doing a walk-through.
  • Other regulations and standards, including ISO 17025
  • Following through on the audit
Who Will Benefit:This webinar will be of benefit to company auditors who need to investigate the qualifications of contract testing laboratories and internal testing facilities. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties. Personnel from companies that perform testing on small molecule drugs, biologicals, and nutraceuticals will benefit from knowing what standards are being applied to them.

The following specific types of workers will benefit from this webinar:
  • External and Internal Auditors
  • Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups.
  • Supervisors and Analysts in Contract Testing Laboratories
  • Personnel Responsible for Selecting Contract Testing Laboratories
  • Consultants


Instructor : Robert J. Russell
Product Id : 30385PACK

Overview: The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

Additionally, changes to the Clinical Trial Directive are being contemplated and the Course Director will provide insight into those areas, which may receive modification.

Learning Objectives: Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this Course has been updated to provide participants with competitive insight into:
  • How to efficiently initiate trials
  • How to link the strategy of Country Selection to an ultimate EU Licensing Plan
  • Efficiently implementing studies via project teams and CROs at the National and multi-state level
  • How to stay compliant…..What can make the difference in your data passing Regulatory scrutiny.
  • Related area-GCP and PV-reporting updates
  • EUCTD vs. FDA Regulations
Areas Covered in the Session:
  • Overview of the EU and the EU Regulatory Structure
  • Marketing Authorization Options in the EU
  • Overview of the European Union Clinical Trial Directive
  • 2007 Pediatric Legislation
  • Processes and Timelines
  • The Ethics Committee
  • Phases of a Clinical Trial
  • Trial Protocol and Project Management
  • Investigational Medicinal Product Dossier
  • Standard Operating Procedures
  • Clinical Trial Authorization Application
  • Good Clinical Practice
  • Good Manufacturing Practice
  • Pharmacovigilance
  • Handling the end of Clinical Trial
  • Clinical Trial Databases
  • European Union vs. The United States
  • Regulatory Process in the EU
  • Recent updates to the Directive

Who Will Benefit:
  • Clinical Operations Staff
  • Project Team Members
  • Quality Assurance, Monitors, CRAs
  • Regulatory Affairs
  • Investigators & Site Study Staff
  • Clinical Trial Supply
  • CROs, Consultants, Insurers


Instructor : Anne Tomalin
Product Id : 30385PACK

Overview: This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.

Discussion will occur regarding the process for changing protocols or clinical trial supplies, including when prior approval of such changes are required. The approach to adverse drug reactions will be discussed. Clinical trial registries are confusing and vary from country to country. The data that must be made public and the timing of these publications has been changing the last several weeks. We will discuss what must be done when a trial is discontinued prematurely or if a regulatory agency refuses to approve your trial.

Why should you Attend:

Knowing the regulatory requirements across these jurisdictions is mandatory for any company trying to conduct clinical trials across these countries. Knowing how a clinical trial is approved, how changes to clinical trials or clinical trial material needs to be submitted, how adverse reactions are handled, how clinical trials are registered and what data needs to be made public are all fundamental issues for companies entering this highly regulated area. This session will provide an overview of these topics and strengthen your knowledge so that you can move forward confidently.

Areas Covered in the Session:

  • Regulatory requirements for Phase I-3 clinical trials to gain approval to conduct the trial
  • Process for approval, when pre-IND meetings or Scientific Advice meetings are useful.
  • Handling changes to protocols or clinical trial supplies.
  • How adverse reactions are handled, including the development of Development Safety Update Reports.
  • How registries fit into the picture.
  • Data that must be made public.
  • How are premature discontinuations of clinical trials handled
  • Requirement if a Regulatory Agency refuses a clinical trial
  • Requirement if an Ethics Board refuses a clinical trial.

Who Will Benefit:

  • Director of Clinical Research
  • Manager of Clinical Research
  • Coordinator of Clinical Research
  • Director of Regulatory Affairs
  • Manager of Regulatory Affairs
  • Manager of Medical Affairs

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 : Steven S. Kuwahara
Product Id : 30385PACK

Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

Areas Covered in the Session:
  • Discussion of the elements found in the guidance document for Phase 1 material.
  • What to do at really early stages.
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product.
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation.

Who Will Benefit:
  • Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions.
  • QA/QC personnel who need to plan work on early stage material
  • R & D personnel who will contribute data to CMC sections.
  • Project managers for product development studies.
  • Quality systems auditors
  • Consultants


Instructor : Jonathan M. Lewis
Product Id : 30385PACK

Overview: Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

Why should you Attend: If you are looking for the answer to the following questions, you will clearly benefit from attending this webinar on building a vendor qualification program which clearly defines the requirements and recommended sustainable implementation:
  • Have you wasted hours, days, and weeks on qualifying vendors that you know cannot or will not meet your requirements?
  • Has your approach to vendor qualification and vendor audits left you with internal CAPAs, customer audit items, or 483 observations?
  • Have you wondered whether an onsite vendor audit is necessary in the eyes of the FDA?

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

Areas Covered in the Session:
  • Structure for a sustainable vendor qualification program
  • How change control and other quality programs feed into the vendor qualification program
  • Audit forms/checklists and other vendor qualification program documents
  • How to determine the best potential vendor
  • What a potential vendor needs to supply before qualification
  • How to initially identify vendors that meet your requirements prior to qualification
  • On-site and off-site verifications
  • Monitoring and re-qualification of vendors
  • How to estimate costs and time associated with vendor qualification
  • Responses to customer and regulatory audit observations associated with vendor qualification
  • Common pitfalls to avoid when qualifying vendors

Who Will Benefit:
  • Internal Auditors
  • Senior Management
  • Compliance Officers
  • QA Managers
  • QC Managers
  • Purchasing Managers


Instructor : Karen Greene
Product Id : 30385PACK

Overview: Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.

The scope of this webinar is to provide those responsible for medical device packaging system design with some key best practices and insights for the design and development of the medical packaging system, sterile barrier system. ISO 11607 part 1 will be the focus, ISO 11607 Part 2, equipment and process validation, will not be addressed. The following seven design essentials will be presented and the author will provide her perspective on how these seven essentials are key to success and efficient time to market for your medical device.

Areas Covered in the Session:
  • Seven Essentials for Successful Medical Packaging Design
    • Packaging Design Requirements
    • Packaging System Hazard Analysis
    • Evaluation of similar or competing devices
    • Clinical application of the Sterile Medical Device
    • Distribution, storage and handling of the medical device
    • Prototype the packaging system
    • Package System Performance Testing

Who Will Benefit:
  • Medical device Packaging Engineers
  • Managers
  • Quality Engineers and Managers
  • Regualtory Affairs Professionals
  • Packaging Technicians.

Karen K. Greene is currently Vice President, Life Packaging Technology LLC, a packaging engineering consulting and services firm. She has been a packaging engineering industry professional for over 30 years. Ms. Greene holds a Bachelor of Arts, Biology, degree from Holy Cross College in Worcester, MA and a professional certificate in engineering management from University of CA, San Diego. She is a certified packaging professional, CPP, the Co- President of the southern California Chapter of the Institute of Packaging Professionals and is a committee chairperson of the IoPP Medical Device Packaging Technical Committee. Ms. Greene is a member of the ASTM F02, Flexible Barrier Packaging committee. She is an ISTA 7E (thermal design and validation) certified auditor.

Ms. Greene is a lead industry consultant for medical device and pharmaceutical package development, validation and production implementation projects and has solved problems related to sterile barrier package integrity, package design, test method development and test method validation and packaging quality related issues. Her expertise extends to cold chain packaging issues, as well. She has held leadership positions with Edwards Lifesciences and IMED Corporation for teams responsible for packaging engineering, documentation, configuration management and label development functions within the medical device industry.

Ms. Greene is sought after for her expertise in developing action plans for compliance to international packaging regulatory standards as well as solving packaging performance problems. She has authored several articles, presented at numerous conferences and conducted webinars on the topic of medical packaging, statistical rationale development for packaging validations and packaging integrity issues.

Instructor : Casper Uldriks
Product Id : 30385PACK

Overview: The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated. That is not a good thing. Otherwise, you hear very little and even then, you may wait a long time. The cloud of doubt can plague a firm for months.

The webinar will cover standard criteria FDA typically uses to select a firm for inspection, classify a firm's compliance profile and to decide what kind of regulatory follow up is required, if any. The investigator is trained to follow certain procedural guidelines and focus on evidence development. The investigator's questions and the documents they collect give you a reasonable picture of where the investigator is going with the inspection. This information may help firm's make their war room mentality a little more sensible.

Why Should you Attend: FDA's inspectional program is more predictable once you understand FDA's inspection selection criteria and the procedures used to conduct inspections. If you apply basic risk and public health concepts, the handwriting on the wall becomes clearer about the likelihood of an inspection. From an investigator's point of view, a firm's war room activity seems like a sequel to Shakespeare's play, "Much Ado about Nothing."

The investigators thinking and actions typically follow predictable directions and are usually based on information you already know. Whether or not an investigator will find your Pandora's Box of problems requires some skill in interpreting the first and second phase of an inspection. Firms are thinking along the lines of "Are they getting hot? Are they getting cold?" How can you tell? That actually is difficult to determine unless you identify the patterns in the investigator's work. Finally, firms invariably ask the investigator at the end of an inspection, "So how did we do?" You will not get an answer, but if you know how to read a list of inspectional observations noted on FDA's Form 483 (483), you can have a good idea. You just need to know some critical factors. In some cases one inspectional observation is sufficient to prompt a Warning Letter from the FDA. In other cases a multi-page 483 will not be sufficient to prompt a Warning Letter. It is not a trial by quantity. You can learn how to sharpen your predictive skills on how FDA will follow up.

Areas Covered in the Session:
  • FDA's annual work plan criteria for inspections
  • FDA's inspectional training and standard procedures
  • Evidence development strategy
  • War room hysteria
  • Inspection classification by FDA and follow up

Who Will Benefit:
  • Regulatory Affairs Directors / Managers
  • Corporate legal counsel
  • FDA consultants
  • Manufacturing Managers
  • Quality Assurance Managers


Instructor : Thomas E. Colonna
Product Id : 30385PACK

Overview: FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
  • FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

Areas Covered in the Session:
  • Definition of dietary supplement
  • DSHEA
  • Good Manufacturing Practices
  • Structure/Function Claims
  • Health Claims

Who Will Benefit:
  • Regulatory professionals working in the field of dietary supplements


Instructor : Adriaan Fruijtier
Product Id : 30385PACK

Overview: On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").

The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, for example:
  • A streamlined application procedure via a single entry point - an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application;
  • A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State;
  • The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty;
  • Strengthened transparency for clinical trials data.

Ethics committees will be involved in the assessment of clinical trials application. However, as with the current situation, their responsibilities and detailed composition will be determined independently by each EU country. In this way the different traditions in the various Member States are respected.

The Regulation, while continuing to uphold patient safety, takes better account of the actual risk to which subjects will be exposed during the clinical trial and adapts the regulatory burden in relation to the risk posed. It introduces the concept of a 'low-intervention clinical trial' - an example being clinical trials comparing already authorized medicines. In such cases, the regulatory requirements will be lighter. The Regulation extends the concept of tacit agreement to avoid bottlenecks and delays in the procedure. This is to alleviate an unnecessary and frustrating restriction that trial sponsors face under the current rules. It is important, however, to emphasize that Member States will always have the possibility to stop any clinical trial, which they consider could endanger the heath of the participants.

Transparency on the conduct and results of clinical trials has several benefits, and the Regulation strengthens the rules accordingly. Transparency avoids redundancy and duplication. It ensures that even clinical trials with unfavorable results are made public, thereby avoiding 'publication bias'. Finally, transparency gives patients the possibility to find out about on-going clinical trials in which they may wish to participate.

The Regulation will ensure that, no matter where a clinical trial is being performed, the fundamental rules for the protection of subjects are applied. It therefore includes rules for clinical trials which are conducted outside the EU but referred to in a clinical trial application within the EU. For such trials, the rules call for compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency.

Why should you Attend: It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval. Especially the procedure for assessment and approval of multinational clinical trial authorisation applications will change. A single authorisation procedure for clinical trials will be introduced that will be performed electronically via a new EU portal In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol. In the Webinar it will be explained how in the new procedure this problem will be avoided.

A detailed knowledge of the new procedure are all key to personal responsible for clinical trial applications. Additionally, the new Regulation will affect how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU clinical trials database will enforce disclosure of clinical trials data and information. The new Regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes now. The timelines for implementation will be discussed in this Webinar to allow optimal preparation.

Areas Covered in the Session:
  • Disadvantages of the current situation
  • Overview of the Clinical Trials Regulation
  • Scope of the Regulation
  • Low intervention clinical trials
  • Milestones
  • EU portal and database
  • Authorisation Procedure
  • Transparency

Who Will Benefit:
  • Regulatory Affairs personnel
  • CRAs
  • Clinical Operations personnel


Instructor : John N. Zorich
Product Id : 30385PACK

Overview: The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple.

The webinar ends with a discussion of how one OEM manufacturer has implemented "confidence/reliability" calculations instead of AQL sampling plans for all of its clients. And suggestions are given for how to use "confidence/reliability" QC specifications instead of "AQL" QC specifications. The use of "reliability plotting" for assessing product reliability during R&D is also discussed.

Why should you attend: Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt, in order to evaluate part quality before the parts Supplier is paid. "AQL" sampling plans are used almost universally for such inspections. However, AQL plans actually provide very little information about part quality. A better way to assess the quality of purchased parts is to use "confidence/reliability" calculations. Such calculations are very easy to perform using tables and/or an electronic spreadsheet.

ISO 9001 and ISO 13485 requirements include establishing "processes needed to demonstrate [product] conformity"; FDA's GMP (21CFR820) requires that "sampling methods are adequate for their use". An AQL sampling plan does not provide what is needed to meet either of those requirements. FDA guidelines state that "A manufacturer shall be prepared to demonstrate the statistical rationale for any sampling plan used" - it is not possible to "demonstrate" that an AQL sampling plan ensures product quality.
On the other hand, confidence/reliability calculations can be easily shown to provide evidence of product quality, and the statistical rationale for such calculations is easy to explain and demonstrate.

Areas Covered in the Session:
  • AQL and LQL sampling plans
  • OC Curves
  • AOQL
  • ANSI Z1.4
  • Squeglia's C=0
  • Confidence/Reliability calculations for
    • Attribute data
    • Normally-distributed variables data
    • Non-Normal data
  • Transformations to Normality
  • K-tables
  • Normal Probability Plot
  • Reliability Plotting

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


Instructor : Jonathan M. Lewis
Product Id : 30385PACK

Overview: Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:
  • How can your company be prepared for an FDA inspection?
  • How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
  • What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

Areas Covered in the Session:
  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection
  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection
  • Define the steps necessary to prepare for an FDA inspection

Who Will Benefit:
  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers


Instructor : Herman Bozenhardt
Product Id : 30385PACK

Overview: The field of biological facility design has been one of the most evolving engineering practices over the last 30 years. In the 1980s most biological facilities were modeled after generations of antibiotic production. These were large and suffered with significant bioburden problems.

By the late 1990s compliance requirements had forced the industry to adapt, and the investment dollars, complexity, and redundancies made the biotech facilities an expensive single product venture. This did not necessarily work out as many of the mega-plant’s sole product did not come to fruition in phase III trials. In the 2000s the biological facilities became smaller by design, were more rapidly deployed and experimented with various technologies to provide regulatory compliance, and in some cases borrowing techniques from the aseptic fill/finish world to assure their success.

In more recent times, design concepts have driven the compliance into a status quo, while the construction techniques and process technology options have allowed production organizations to build quicker, at lower cost per square foot. The process technologies, specifically the disposables have been a game changer with respect to multiple product facilities, introduction of cyto toxic compounds, smaller footprint, and easier operations.

This webinar will explore the design concepts that are driving the compliance and the operability of the business. The exploration will be a “inside – out” view of a plant’s design model:
  • Process Core
  • Facility Design
  • Facility Operations
  • HVAC
  • Utilities
  • Qualifications

Why should you Attend: The pharmaceutical world is driving two contemporary themes: 1) rapid modification of existing (possibly old) biological production to accommodate new products, therapies and cell cultures, and 2) rapid design and build of a new facility on an existing site to launch a new product. All these projects have two aspects in common, rapid and risk.

Today most companies delay any decision, and when doing so making until it almost too late to act, and that leads to risk in design and deployment. In addition, early on in the process an ill defined budget is usually fixed and becomes a burden to those responsible for the effort. This type of dilemma ultimately manifests itself with compliance risks unless the organization has the background in some of the new technologies as well as the key design features that will prevent compliance issues from the US and EU. This webinar looks at key design features and philosophies to drive the compliance to a successful conclusion, and will explore modern technologies of facility deployment that can rein in costs and reduce schedules.

Areas Covered in the Session:
  • Facility design direction and features (architectural and HVAC)
  • Process design features and options
  • Bioburden Control
  • Potent / Cyto-Toxic vs. Non-Toxic Compounds
  • Process Disposables / Single Use Technologies
  • Project Execution Methods
  • Automation
  • Risk Based Qualifications
  • Operational Do’s and Don’ts
  • Off Site Qualifications
  • Modular / Podular design
  • Utility Systems (water, air, gases, etc.) and options
  • Enabling Good Aseptic Technique
  • Environmental Monitoring

Who Will Benefit:
  • Engineering
  • Operations
  • Planners
  • Project Planners
  • Quality Assurance


Instructor : Jerry Lanese
Product Id : 30385PACK

Overview: Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

By careful review and analysis of the regulations, inspectional guidance, 483 observations and Warning Letter, internal audit observations and deviations, along with a review of laboratory practice and procedures, a laboratory can proactively identify areas for improvement. The laboratory can then implement actions that will prevent future observations of non-compliance. In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and provide a stimulus to initiate preventive actions.

Why should you Attend: A large number of FDA 483 observations are made in Quality Control Laboratories. All laboratory personnel should be aware of areas the investigators review and the type of observations that are made in other organizations. With this information, laboratory personnel should be look for ways that their laboratory operations can be improved to avoid these observations.

In this webinar the discussion will begin by identifying non-conformances most often cited by the FDA and the pertinent regulation. This will be followed by a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. The discussion for each observation will include an analysis of what went wrong, systems, procedures and records the laboratory should have in place that would prevent a similar observation and several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and being followed.

After completion of this seminar, laboratory personnel will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement.

Areas Covered in the Session:
  • System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • 483 and Warning letter observations
  • Analysis of observations
  • Areas for preventive action

Who Will Benefit:
  • Quality Control Laboratory Managers
  • Quality Control Laboratory Supervisors
  • Quality Control Analysts
  • Quality Control Microbiologists
  • Quality Assurance Manages
  • Quality Auditors


Instructor : Heath Rushing
Product Id : 30385PACK

Overview: This course will focus on teaching how to efficiently and effectively apply recommended statistical methods and tools to process validation. Using hands-on exercises (complete with realistic process data), participants will learn how to apply these tools, interpret results, and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

In the application of statistical methods in IQ, the following will be discussed and demonstrated: sample size calculations and power, hypothesis testing and confidence intervals, and measurement systems analysis (MSA). In the application of statistical methods in OQ, the following will be discussed and demonstrated: failure modes and effects analysis (FMEA) and cause-and-effect diagrams, statistical process control (SPC), design of experiments (DOE) as well as response surface methodology (RSM), and process capability. In the application of statistical methods in PQ, the following will be discussed and demonstrations: SPC, process capability, and FMEA.

Although this is not a course on statistical theory, participants will gain an understanding and exposure to the appropriate statistical methods that should be applied through process validation.

Why should you Attend: According to 21 CFR Part 820, medical device manufacturers are required to validate as well as monitor and control parameters for their processes. The guideline on Quality Management Systems does not specify how this is accomplished; only that "a process is established that can consistently conform to requirements" and "studies are conducted demonstrating" this. Thorough process development, optimization, and control using appropriate statistical methods and tools are recommended for demonstrating your process is both stable and capable.

Areas Covered in the Session:
  • Know which statistical methods are recommended by the guidance documents
  • Understand where these statistical methods should be applied
  • Understand different types of data intervals
  • Understand the benefits of a measurement systems analysis (MSA)
  • Be able to analyze a hypothesis test and interpret data intervals
  • Be able to design and analyze an experiment
  • Be able to generate and interpret process control charts and capability indices

Who Will Benefit:
  • Process Engineer
  • Design Engineer
  • Design Controls Engineer
  • Six Sigma Green Belt
  • Six Sigma Black Belt
  • Product Development Engineer
  • Continuous Improvement Manager


Instructor : Dr. Ludwig Huber
Product Id : 30385PACK

Overview: Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime.

In addition audits are also an excellent tool to prepare your organization and staff for external audits, e.g., FDA inspection.. However, without a clear strategy audits can become quite complex and ineffective. This seminar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

Reference material for easy implementation:
  • SOPs: Validation of Commercial Off-the-Shelf Computer Systems
  • Checklist: Using computers in FDA regulated environments
  • Validation templates and examples

Areas Covered in the Session:
  • Regulatory requirements: FDA, EU, PIC/S
  • Audit recommendations from the FDA Quality System guidance for cGMPs
  • Effective development and use of audit checklists
  • Developing an SOP for audits of computer systems.
  • Assigning responsibilities
  • Conducting the audit: review procedures, walk through the computer system area
  • Most critical questions to ask
  • Auditing for data integrity
  • Auditing in preparation for FDA's ongoing Part 11 initiative
  • Documenting detailed audit findings
  • The audit summary report
  • Effective follow up
  • Presenting evidence of the audit to the FDA
  • Case study: going through a life audit

Who Will Benefit:
  • QA managers and personnel
  • QC and Lab managers
  • IT managers and system administrators
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants


Instructor : Karen Greene
Product Id : 30385PACK

Overview: Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.

Areas Covered in the Session:
  • Statistical Rationales-the importance and application of developing an appropriate sample size for testing
  • Compliance and guidance for:
    • Medical device sterile barrier systems
  • Determining sample size for sterile barrier systems (packaging systems)
    • A process for developing an appropriate and statistically valid test population
  • Summary of key takeaways of non-statistically significant survey of medical device companies on statistical rationales
  • Wrap Up
  • Question and answer

Who Will Benefit:
  • Packaging and Quality Engineers
  • Packaging and Quality Managers
  • Test Engineers

Karen K. Greene is currently Vice President, Life Packaging Technology LLC, a packaging engineering consulting and services firm. She has been a packaging engineering industry professional for over 30 years. Ms. Greene holds a Bachelor of Arts, Biology, degree from Holy Cross College in Worcester, MA and a professional certificate in engineering management from University of CA, San Diego. She is a certified packaging professional, CPP, the Co- President of the southern California Chapter of the Institute of Packaging Professionals and is a committee chairperson of the IoPP Medical Device Packaging Technical Committee. Ms. Greene is a member of the ASTM F02, Flexible Barrier Packaging committee. She is an ISTA 7E (thermal design and validation) certified auditor.

Ms. Greene is a lead industry consultant for medical device and pharmaceutical package development, validation and production implementation projects and has solved problems related to sterile barrier package integrity, package design, test method development and test method validation and packaging quality related issues. Her expertise extends to cold chain packaging issues, as well. She has held leadership positions with Edwards Lifesciences and IMED Corporation for teams responsible for packaging engineering, documentation, configuration management and label development functions within the medical device industry.

Ms. Greene is sought after for her expertise in developing action plans for compliance to international packaging regulatory standards as well as solving packaging performance problems. She has authored several articles, presented at numerous conferences and conducted webinars on the topic of medical packaging, statistical rationale development for packaging validations and packaging integrity issues.

Instructor : Jonathan M. Lewis
Product Id : 30385PACK

Overview: Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:
  • How can your company be prepared for an FDA inspection?
  • How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
  • What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

Areas Covered in the Session:
  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection
  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection
  • Define the steps necessary to prepare for an FDA inspection

Who Will Benefit:
  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers


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