Duration: 60 Minutes


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This conference is intended to help you get familiar with the FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements applicable to the FDA-regulated industry (drugs, biologics/biosimilars and medical devices including IVDs).

This session by our expert speaker, Dr. David Lim, is further intended to increase our awareness that an adequate implementation and management of part 11 and computer system validation can greatly increase patient safety by reducing the likelihood of compromising data quality and integrity including computer system validation.

FDA frequently states “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; “failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….”

This session will address the best practices to ensure an adequate implementation of part 11 and computer system validation requirements including how to avoid 483s and warning letters concerning part 11 and computer system validation.

Our presenter will walk you through the FDA compliant practices. This conference will provide great opportunities to improve your awareness and better implement part 11 and computer system validation requirements and to avoid citations in 483s and warning letters concerning part 11 and computer system validation.

For easy implementation, attendees will receive:

  • Checklist: Part 11 compliance
  • Case studies: How to avoid Part 11 related 483s and Warning Letters
  • SOP: Electronic audit trail – specifications, implementation, validation

Session Highlights:

  • Laws and Regulations
  • Definitions
  • Regulatory Requirements under 21 CFR Part 11
  • FDA Inspection and Management
  • Form FDA 483, Warning Letter and Consent Decree/Permanent Injunction
  • Lessons Learned from Data Integrity, Quality and Fraud
  • FDA Enforcement on Data Quality and Integrity
  • FDA Actions on Part 11 and Computer System Validation
  • FDA Enforcement Examples (483s and Warning Letters) on Part 11
  • Common FDA Enforcement Findings on Computer Validation
  • Common Problems/Causes for FDA Findings in 483s and Warning Letters Regarding Part 11 and Computer System Validation.
  • Do We Have to Respond to 483s?  HOW?
  • How to Avoid Citations in 483s?
  • How to Best Implement Part 11 Requirements
  • How to Validate Computer Systems
  • Best Practices: Dos and Don’ts

Areas Covered in the Session :

  • FDA inspections – preparation, conducts, follow up
  • The meaning of Warning Letters and 483 inspectional observations
  • Learning from an FDA presentation: Data Integrity and Fraud – Another Looming Crisis?
  • Data integrity and authenticity: FDA’s new focus during inspections
  • Examples of recent Part 11 related 483s and Warning Letters
  • Examples of recent 483s and Warning Letters related to computer system validation
  • Most obvious reasons for deviations
  • Avoiding and responding to 483s: going through case studies
  • Writing corrective and preventive action plans as follow up to 483s
  • Using internal audits to prepare yourself for Part 11 related FDA inspections
  • Strategies and tools for compliant Part 11 implementation
  • The future of Part 11 and computer system validation

Who Should Attend:

  • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • IT Professionals
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

Course Director: DR. DAVID LIM ‎

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.