Discussion on FDA’s new focus during inspection of computer systems and e-records, reasons for deviations and how to write CAPA plans to avoid 483 and respond to 483’s to avoid warning letters.
Why Should You Attend:
David Horowitz from the FDA made it very clear: There will be fewer warning letters but they speak louder. All FDA warning letters now have to be approved by FDA management. They do not express the opinion of single inspectors but FDA's current thinking. They are much more up-to-date than regulations and FDA guidelines. The new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2009, there have been more than 30 deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies.
With the streamlining of focus of FDA for issuing a warning letter and more deviations being cited in recent times related to CSV and Part 11 compliance, it is essential for companies to learn how to get a correct meaning of warning letters, what are the reasons for deviations, how to respond to the 483’s and write CAPA plans to avoid warning letters.Attend this Webinar and listen to our expert Dr. Ludwig Huber explain the strategies to avoid warning letters using examples of recent 483’s and warning letters related to CSV.
Hand-Outs:
For easy implementation, attendees will receive
- SOP: Define and Document Scope and Controls for Part 11.
- Checklist: Part 11 Compliance.
- 15 Case Studies.
- All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and justifications for the FDA and your management
- 20+ Warning letters and Inspectional observations related to 21 CFR Part11, all from 2006-2009.
Areas Covered in the Seminar:
- 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.
- FDA's new focus during inspections of computer systems and e-records.
- Examples of recent Part11 483’s and warning Letters.
- Examples of recent 483’ and warning letters related to computer system validation.
- Most obvious reasons for deviations.
- Responding to 483's to avoid warning letters.
- Writing corrective and preventive action plans to avoid 483.
- The future of Part 11and computer system validation.
Who Will Benefit:
- Pharmaceutical, API and Medical Device Industry
- Part 11 groups in Bio(pharmaceutical) and device industry
- Software developers
- IT managers and system administrators
- QA managers and personnel.
- Analysts and lab managers
- Validation professionals
- Training departments
- Documentation department
- Consultants
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com
