Pack of SEVEN: Best Selling Medical Devices Webinars by GlobalCompliancePanel

Webinar# 1

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements

Overview: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.

It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices.

Areas Covered in the Session:

Regulatory definitions of recalls, removals, and market corrections
Instances which require recalls, removals, or market corrections
What to do during recalls, removals, and market corrections
Recordkeeping requirements for recalls, removals, and market corrections
ISO 13485-specific requirements
CMD-specific requirements (Canadian device regulations)

Who Will Benefit:

Regulatory Management
Quality Assurance Professionals
Consultants
Sales/Marketing Management
Senior and mid-level Management
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Webinar# 2

Risk-based Software Verification and Validation

Overview: This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:
1) As-Product
2) In-Product
3) In Production and Test Equipment, and
4) The Quality System.

A manufacturer is responsible to identify those risks, and take reasonable steps to address them in the software validation process. The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Webinar# 3

The Design History File and the Technical File / Design Dossier

Overview: The DHF is a key element of Design Control under the GMPs, and is a major subject for review during a U.S FDA compliance audit.

The EU’s MDD Technical File / Design Dossier serve a different purpose, showing conformity to the MDD and associated applicable standards and the rationale for the CE mark. Each is subject to different requirements and expectations on the part of the reviewer / auditor. As such they are compiled differently, requiring differing mindsets and documentation.

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Webinar# 4

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

Overview: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Why you should attend: What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance.

Areas Covered in the Session:

How to prepare for an FDA inspection?
Development and contents of an SOP for FDA inspection.
Reliance of FDA inspectors on compliance program guide manuals.
Reliance of FDA inspectors on other external sources.
Personnel training before inspection.
In depth review and summary of QSIT.
Use of QSIT for internal auditing.

Who Will Benefit:The employees who will benefit include:

Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Webinar# 5

FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators

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, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.

Webinar# 6

Regulatory Complaint Handling, MDR's & Recalls

Overview: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling.

This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and has even driven the firm's stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

Webinar# 7

Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements

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 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, 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 be considered.

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.