Training on FDA’s new focus during inspections of computer systems and e-records, reasons for deviations and how to avoid 483 and respond to 483s to avoid warning letters.
Why Should You Attend:
In July 2010, the FDA announced that it will conduct a series of inspections related to 21 CFR Part 11. The FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the Guidance from 2003.
While this guidance leaves a lot of room for interpretation and uncertainty, an excellent way to find out FDA's expectations is to learn from recent Part 11 related warning letters. From 2007-2011, there have already been more than 30 warning letters with deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies.
This webinar will explain the strategies to avoid warning letters using examples of recent 483’s and warning letters related to computer system validation.
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.
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
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
