Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Improve Your Awareness Of FDA Compliant Practices 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

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.

David 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.

Why Should You Attend:

Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative, FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the guidance from 2003. In the meantime, FDA officials reported key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.

Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.

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


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

Areas Covered in the Webinar:

  • 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

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


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