The Center for Professional Innovation & Education (CfPIE), Dublin, Ireland
Mar. 5 & 6, 2007
Who Should AttendThis course is directed toward those who are responsible for research, development, manufacture, marketing, quality, and/or regulatory compliance within the pharmaceutical and medical device industries. The course will benefit individuals whose job functions include operations governed or overseen by FDA regulations including personnel involved in preparing for, participating in and responding to FDA inspections. Managers, including executive management, will benefit by learning what their direct responsibilities and vulnerabilities are as a result of GMP inspections. Learning Objectives This program is designed to provide attendees with the tools and knowledge necessary to upgrade their quality system to current GMP levels. In addition to providing the latest FDA expectations for compliance with Drug and Device GMPs, attendees will learn how to prepare, manage and successfully complete an FDA inspection. Upon completion of this two-day course, the participants will gain comprehensive insight into the FDA’s latest expectations when conducting investigations and how to audit effectively for compliance with those expectations in mind. Course Description Personnel attending this interactive program will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials and how to respond to FDA observations. Additionally this course is a good refresher for all personnel involved in the FDA inspection process and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format. The following are examples of some of the issues addressed during the course: • What your organization can do to prepare for the inspection
• What information can the FDA request during an inspection
• Can a Warning Letter be issued immediately after an FDA inspection
• When can the FDA take action without issuing a Warning Letter
• What does the FDA look for during inspections
• How does the FDA classify a recall
• What are the timeframes for the U.S. DOJ's and FDA's handling of clear criminal fraud cases
• What type of documentation is required and what is the correct format
• What do the FDA's export regulations mean to your firm
• What types of cases does the FDA refer to the DOJ for prosecution
• When can the FDA suspend, deny or withdraw abbreviated new drug applications (ANDAs)
• How to respond to FDA actions
• Under what conditions can the FDA debar companies and individuals
• What to do after the FDA has taken action ________________________________________
COURSE AGENDA DAY ONE FDA Organization and Enforcement
• FDA Strategy and Organization
• The Law and Regulations
• Formal Enforcement Tools
• Informal Enforcement Tools Latest FDA Issues and Initiatives
• Top 5 Warning Letters
• Top 10 Drug 483’s
• Top 10 Device 483’s
• FDA Initiatives and Changes Management Responsibility – Latest Expectations
• Executive Vulnerability
• Organization
• Training
• Audits
• Management Reviews Corrective & Preventive Action (CAPA) – Latest Expectations
• New Definitions
• Non-conformances Versus Deviations
• Expected Elements Of CAPA System GMP Documents & Documentation Requirements
• Types and Controls
• Problem Areas
• Change Control Problems
• Quality Records Review Out Of Specification (OOS) – Latest Expectations
• Scope of OOS
• Laboratory Investigation
• Production Investigation
• Copy of OOS Guideline
• Sample Warning Letters DAY TWO Part 11 Elec. Signature/Records – Latest Expectations
• Current Focus
• Warning Letter Issues Product Development & Design Control – Latest Expectations
• Product Development Regulations
• Most Frequent observations
• Documentation Expectations QSIT – Current FDA Inspection Approach
• What QSIT Is
• How QSIT Works Complaint Handling – Your 1st Line Of Defense
• Aspects Inspected
• Records Requirements
• Tracking and Trending FDA Inspection Do’s and Don’ts
• Procedure For Inspection Accommodation
• Records Readiness
• Who To Include/Not Include
• What To Say/Not To Say Triaging a Form FD 483
• Developing Initial Response
• Timeliness Of Response
• How To Challenge/Dispute A 483 Why Internal Audit Systems Fail
• The Pass/Fail Criteria
• Auditor Versus Verifier
• Auditor Fear Factors
• Inadequate Auditor Accountability
• Ineffective Audit Schedule/Plan
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