Duration: 75 Minutes


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FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

For easy implementation, attendees will receive three SOPs

  • Checklist: Part 11 compliance
  • Case Studies: How to avoid Part 11 related 483’s and Warning Letters
  • SOP: Electronic Audit trail: Specifications, Implementation, Validation

Areas Covered in the Session :

  • FDA’s current inspection and enforcement practices
  • FDA’s new interpretation: learning from FDA inspection reports
  • Strategy for cost-effective implementation of Part 11: A six step plan
  • Recommended changes to existing Part 11 programs to reduce costs
  • Justification and documentation for the FDA and your management
  • Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
  • Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.
  • How to prepare your company for Part 11 Inspections

Who Should Attend:

A must attend webinar for professionals in Small, midsize and large Pharmaceutical companies, API manufacturers, Contract laboratories, Clinical testing laboratories, CROs, Medical device industry. The professionals who will benefit include all:

  • QC managers
  • QA managers and personnel
  • IT administrators
  • Analysts
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

Course Director: DR. LUDWIG HUBER

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).