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Instructor : John E Lincoln
Product Id : 30376PACK

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must also be considered.

Why Should You Attend: Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased.

Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, are not documented in a top tier Master Validation Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.

Areas Covered in the Session:
  • Verification or Validation - Recent regulatory expectations
  • The Master Validation Plan and its structure
  • Product Validation - how it differs from process / equipment V&V
  • Process / Equipment / Facility Validation - including FDA's recent guidance
  • When and How to use DQ, IQ, OQ, PQ, or their equivalents
  • How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
  • The 11 key documents for software validation
  • Incorporating 21 CFR Part 11 requirements
  • Suggested "test case" formats

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants

Instructor : Karl Leinsing
Product Id : 30376PACK

Overview: We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.

The process is a methodical approach that can be used with almost any product development process from concept to production. The speaker has a proven track record of successful products and many of them have been on the market longer than the 5 or 10 year expected product life cycle. The speaker has 20 granted patents and over 83% percent of them have been commercialized and using this process.

Why should you Attend:

The medical device development process can be long and costly, but not if you follow some proven guidelines and steps. Sometimes projects are continuously pushed forward without doing proper reviews to see if the project warrants going to the next step. The sooner this process is done the better as it saves time and money. Good products also need to be completed faster and with less capital to beat the competition to market and beat them with a good quality product that needs little to no revisions and one that receives very few to no complaints from the customer. We will teach you the secrets of turning your medical device ideas into profit making products, which are the same steps that can also enable you to see why the project should be cancelled.

Areas Covered in the Session:

  • How to start a development project.
  • Patent search
  • Putting together a comprehensive systems requirement document.
  • 1-10-100 Rule
  • Market research and customer needs
  • Design in quality & manufacturability
  • Prototype & testing
  • Production Tooling
  • Qualification, Validation, & Verification
  • Trace Matrix
  • Technical File & Regulatory Documentation

Who Will Benefit:

  • Medical Device Design Engineers
  • Product Managers
  • Directors of Product Development
  • VP of Product Development
  • Inventors
  • Project Leaders
  • Technical Team Leaders

Instructor : Leo Lagrotte
Product Id : 30376PACK

Overview: As an experienced FDA medical device investigator, approximately 90% of all FDA 483 I've issued contained inspectional observations that included firm's inability to establish and implement Complaint Handling procedures in compliance with 21 CFR 820, or failed to follow their own established procedures. Either way can get a firm into sufficient Warning Letter territory.

There are requirements for every medical device firm to comply in both FDA and ISO 13485 for the properly collection, investigation, root cause determination and corrective actions required when a complaint is received requiring properly handled of each complaint within your organizations. What are the pitfalls in Complaint Handling? We will discuss many of these during the webinar and provide sufficient time for specific questions. Please bring some of your most challenging complaints for discussion. This will benefit all attendees.

Why should you Attend: Many medical device firms struggle deciding when a complaint is a complaint and when to investigate. There are specific definitions in 21 CFR 820.198 which provide information as to the requirements for Complaint Handling; however, some firms have difficulty implementing these regulations.

This webinar will assist the viewer with how to determine if a customer call should be handled as a complaint, service call or just an inquiry. I will provide information expected to be performed by you on all service calls logged by your firm. Sufficient time will be provided for Q&A.

Areas Covered in the Session:
  • What is a Complaint
  • What is an Inquiry
  • Who in your firm should take complaints
  • How to Handle Service Reports
  • When to report to FDA
  • How to report to FDA

Who Will Benefit:
  • All Medical Device manufacturers
  • Medical Device Investigator
  • Risk Management Specialists
  • QA Managers
  • Regulatory/Legislative Affairs Professionals
  • R&D and engineering staff

Leo Lagrotte Currently serves as a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years’ experience with the FDA and USDA. Mr. Lagrotte’s previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.

His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004. He also served on the Medical Device Inspection Cadre and conducted over thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically. Presently, Mr. Lagrotte’s focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients.

At FDA and USDA he received numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.

Instructor : Jeff Kasoff
Product Id : 30376PACK

Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session:
  • FDA and ISO requirements for complaint handling
  • Establishment of complaint handling program
  • What constitutes a complaint
  • ISO-specific implications of complaint handling
  • The roles of investigation and corrective action in complaint handling
  • Complaint trending and reporting
  • Application of risk management to complaint handling program

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • Regulatory management
  • QA management
  • Customer Service personnel
  • Sales personnel
  • Consultants
  • Quality system auditors

Instructor : Anna Longwell
Product Id : 30376PACK

Overview: The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. The decision has to be made by the manufacturer, subject to review by the FDA inspector. This talk will provide quality and regulatory personnel the means to help to the company make the right decision and document it fully, before the change goes through.

Why should you Attend: Failure to file a 510(k) for a change to a product which has already been cleared under 510(k) is one of the more frequent complaints in 483's and in warning letters. The result of this finding is the requirement to file a 510(k) for a product that is on the market, and usually, to file a 510(k) and have the change cleared before the product can be marketed with the change. In general, FDA will not insist on recalling product with the change already in the market unless they decide there is a safety issue, but even so, this means disruption of the manufacturing (already producing the changed product) and marketing for the product. The best approach is to understand what FDA means by a "significant change" and document completely the reasons why you believe the change does not warrant a filing.

Areas Covered in the Session:
  • Background: the regulation
  • Guidance and FDA expectations
  • Concrete examples
  • Analysis (consecutive changes)and checklist
  • Documentation

Who Will Benefit:
  • QA and RA specialists
  • QA and RA managers

Anna Longwellis currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams. Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC. Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled “Due Diligence Points to Consider” in the “Expert’s Guide to Healthcare Product Due Diligence” published by FDLI.

Ms. Longwell holds a bachelor’s degree in Chemistry from San Francisco College for Women (now USF), a Master’s degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).

Instructor : Jerry Dalfors
Product Id : 30376PACK

Overview: Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.

During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs. Generating very large frozen particles due to the initial freezing process can cause the sedimentation rate to go way up causing a much longer cycle than effective design of the process can accomplish making the process more cost effective and higher quality.

Why should you Attend: The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. Principles and concepts presented are later used to discuss real world pracdtical applications. The long term training sessions include participants in development, operations, engineering, technical services, quality, validation, and regulatory affairs. Brief on-line training addresses critical aspects of freeze drying to ensure compliance, validation and minimization of patient risk based on the development of the product proven to have been during the clinical trials before the product was transferred into commercial scale operations.

Areas Covered in the Session:
  • Essentially a brief discussion about each of the Critical Aspects and related affects of Variables
  • Lyophilization 101 – Comprehension on each step of the Freeze Drying/Lyophilization Process
  • Understanding why various steps of the process become more advantageous and cost effective
  • Sublimation Rate Variability
  • Heat Transfer
  • Loss of Protein Activity
  • Freezing Affects on Primary Drying
  • Optimization of Primary Drying and Proof of the effectiveness of Secondary Drying
  • Effects of Freezing Method and Excipients on Protein Surface
  • Influence of Packing Density and the container selection
  • Residual Moisture Regulatory Considerations by the FDA

Who Will Benefit:
  • Compliance Manager
  • Process Engineer
  • Validation Manager
  • Regulatory Manager

Instructor : David R Dills
Product Id : 30376PACK

Overview: Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry.

This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E-Imports and Exports. Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. The affirmation of compliance should include: importer registration number, foreign establishment registration number and name of U.S. agent, medical device listing number, and Premarket Notification 510(k) or Premarket Approval number, if applicable. For exporting, while FDA does not place any restrictions on the export of devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). Learn the process for unapproved and approved medical devices to be exported and the documentation process involved.

Areas Covered in the Session:
  • Examine the import and export requirements for medical devices
  • Introduction to FDA references and guidance documents related to import and export requirements
  • Understand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S.
  • Import Alerts
  • Recordkeeping requirements and your responsibilities
  • How to export unapproved and approved medical devices

Who Will Benefit:
  • All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import process
  • Regulatory Affairs
  • Clinical Affairs
  • Quality and Compliance
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • 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 : John E Lincoln
Product Id : 30376PACK

Overview: This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.

The U.S. FDA has stated that the use of a medical device entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 provides an accepted vehicle by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.

Areas Covered in the Session:
  • The Revised ISO 14971:2007
  • Product Hazard Analysis
  • Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
  • Fault Tree Analysis
  • The Team and It's Involvement – Who, When and How
  • Product Risk Management File and Report
  • Using the Completed Document – It’s Real Value
  • Keeping it "In the Loop"
  • A "Living Document"

Who Will Benefit:
  • Senior Management, Project Leaders
  • Internal / External Auditors and/or Consultants
  • Regulatory Affairs
  • Quality Systems Personnel / QAE
  • New Product Development, Marketing and R&D
  • Product and Process / Manufacturing Engineering Staff
  • Document Control

Instructor : John E Lincoln
Product Id : 30376PACK

Overview: The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.

Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area gaining attention is a company’s suppliers, for both services and products / components.  Why needed? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting supplier buy-in. Coping with "rogue" suppliers.

Areas Covered in the Session:
  • Regulatory "Hot Buttons"
  • Classify suppliers
  • Supplier requirements by "classification"
  • The site audit
  • Types of remote audits
  • Maintaining the relationship

Who Will Benefit:
  • Senior Management, Project Leaders, Internal / External Consultants
  • Mid-level management and supervisory personnel
  • Corporate and site coordinators
  • Regulatory Affairs
  • Quality systems personnel / QAE
  • R&D and engineering staff
  • Purchasing personnel
  • New product development personnel

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