Source: http://www.complianceonline.com/understanding-fda-new-part-11-inspection-program-webinar-training-701743-prdw
Timestamp: 2017-03-29 19:34:24
Document Index: 248443312

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

FDA Part 11 Inspection, Electronic Records, Signatures, Documentation : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com
› Understanding and Preparing for FDA's New Part 11 Inspection Program
Product ID: 701743 Duration: 93 Min recorded version
This Part 11 Inspection training will answer all
questions related to the new part 11 inspection program by FDA and FDA
expectation of implementing part 11 requirements.
Why Should You Attend:Within the next few months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. There are many questions about the program and further steps: How are companies selected for the inspections?, Are 3rd party service providers part of the program, e.g., CROs? Will the outcome of inspections be made available to the public, e.g., through warning letters? When exactly will the program start and how long will it last? How many inspections will be part of the program? Could preclinical (GLP) studies be part of the program? Will there be a dedicated Part 11 inspection team? Are inspectors trained on what to look specifically? It seems, that record integrity is a key issue, Is there a standard how records are protected ? Will inspections take longer because of Part 11? What are the recommendations for clinical record systems? How will the program impact inspections of Medical Device manufacturers? And many more...
This seminar will give a good understanding of the FDA inspection program and will help attendees to prepare them for the inspections. The speaker will give very detailed information on the FDA program and answer all questions above and more. He also will provide information on FDA's expectation how Part 11 requirements should be implemented.
FDA inspections: Preparation, conducts, follow up. Scope of the new Part 11 program: time frame, expected outcome.
How to avoid Part 11 related 483's and Warning Letters
How to respond to Part 11 related 483's and Warning Letters
30 FDA Warning Letters from 2007 to 2010 (Web downloads) with deviations related to computer systems and Part 11 compliance.
Pharmaceutical and medical device industry.
Manufacturers of pharmaceutical ingredients.
Contract manufacturers and laboratories.
IT managers and system administrators.
Part 11 project managers.
QA managers and personnel.
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 .