FDA Auditing of Computerized Systems and Part 11

 

Monday, Tuesday and Wednesday (8:30 a.m. - 5:30 p.m.)

 

 Hands-On Part 11 Training

 From the Same Instructors Who Trained the FDA

 

      -  September 21-23, 2009, St. Paul, MN

      -  March 22-24, 2010, Las Vegas, NV

 

 Keep your company safe from FDA’s stepped-up enforcement in two areas directly impacted by Part 11
 and computer systems validation:

 

  1. Data integrity, especially in clinical and manufacturing environments, and
  2. Supplier quality assurance

 

 Receive expert advice from ex-FDA senior officials and industry authorities who trained
 FDA’s own field inspectors to investigate and interpret CSV and 21CFR Part 11 compliance.

 
 

 You’ll learn:
 

  • Which validation deliverables the FDA expects and what they should contain
  • Why lots of compliance dollars and resources are wasted on ineffective or inadequate validation
  • How to identify, document and report computerized system validation deviations
  • Top validation errors cited in FDA enforcement actions
  • Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
  • Part 11 rules for electronic records and signatures
  • Paper vs. electronic? Ensuring electronic data correlates to paper records
  • Key principles of computerized system validation
  • Change control and configuration management
  • Ensuring audit trails and secure data access and transfer
  • Evaluating software vendor compliance claims
  • Current status of Part 11 – revisions, rewrite or abandonment
  • How to prepare for the FDA inspector – using a simulated inspection with real-world scenarios


 Course Content:

·         FDA and Computerized System Validation

o    Which validation deliverables the FDA expects and what they should contain

o    Why so many compliance dollars and resources are wasted on ineffective or inadequate validation

o    How the FDA defines a systems risk, plus mitigation strategies you can deploy

 

·         FDA Guidance on Part 11 Scope and Application

o    Part 11 rules for electronic records and signatures

o    Paper vs. electronic? Ensuring electronic data correlates to paper records

o    Why data integrity is critical with or without Part 11

o    Current status of Part 11 – revisions, rewrite or abandonment?

 

·         Computerized System Development Model and Methods

o    Proven techniques for developing compliant software

o    Change control and configuration management

o    Data and information resources

 

·         Key Principles and Techniques for Computerized System Validation

o    Five pillars required for effective CSV, including: system management and monitoring,
system change management, vendor management and CSV methodology management

o    Keys to maintaining your systems in a validated state

o    How to identify, document and report computerized system validation deviations

o    Ensuring audit trails and secure data access and transfer

o    Applying CSV to various types of systems, including legacy systems

o    Evaluating software vendor compliance claims

 

·         Regulatory Enforcement – Overview and Recent Trends

o    Top validation errors cited in FDA enforcement actions

o    Proactive steps to avoid CSV and Part 11 Form 483s and warning letters

 

·         Workshop: Exercises and Simulated Inspection of Computerized System Development

o    How to prepare for the FDA inspector – using a simulated inspection with real-world scenarios

o    Learn how to apply effective auditing techniques

 

To Register or Get More Details:

Email Cece Bland, Director of Training and Information Services, at Info@EduQuest.net
or call +1 (301) 874-6031.  Tuition is $2795 with discounts for teams of 5 or more.

 

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