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Timestamp: 2017-10-24 02:07:15
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Understanding and Preparing for FDA's Part 11 Inspection Program
1) George Smith: CDER Part 11 Inspection Assignments (July 2010)
2) Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?
3) Steve Wilson: FDA Regulatory Perspective on Data Integrity
The reference material includes links to FDA and international regulations and guidelines
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We have received very positive feedback from attendees of this and previous seminars related to Part 11. To learn how the seminar helped to understand and implement Part 11 and to prepare companies for Part 11 inspections, click here.
On-line Audio Seminar 250
Understanding and Preparing for FDA's New Part 11 Inspection Program
Within the next few weeks and 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:
Key Questions related to FDA's Part 11 Inspection Program are:
How are companies selected for the inspections?
Are companies selected based on submissions to the FDA?
Are 3rd party service providers part of the program, e.g., CROs?
Will there be a list of companies that will be inspected?
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?
Is the material used to train inspectors available to the the public, and if so how can we get it?
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?
Will there be a process to review the inspection reports to ensure consistency?
Are there certain things inspectors will always look at?
Will there be a standard inspection questionnaire?
What are the recommendations for clinical record systems?
How will the program impact inspections of Medical Device manufacturers?
Validation is one important requirement, is there a guidance from the FDA?
How should we prepare our department for inspections?
How can we fix most critical Part 11 issues short term?
Is enforcement discretion still applied and if yes for which requirements?
What are the most likely Part 11 steps after this program?
Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, 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.. After the seminar, an extensive list of reference material like case studies, SOPs, checklists and templates will help immediate and cost effective implementation of a Part 11 program that is in line with current and future FDA's expectations. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.
FDA inspections: Preparation, conducts, follow up
Scope of the new Part 11 program: time frame, expected outcome
Criteria for selection of target companies
What inspectors are looking for
How to prepare your company for the upcoming inspections
Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations
How to fill gaps short term
Developing a program for long term
Creating the right documentation to satisfy the inspectors
Most likely next steps after the inspection program
Part 11 Compliance Master Plan
Part 11: Step-by-step Implementation
Four example SOPs:
- 21 CFR Part 11: Scope and Controls
- FDA Inspections: Preparation, conduct, follow up
- Electronic Audit Trail: Specifications, Implementation, Validation
- Retention and Archiving of Electronic Records
- Requirement Specifications: Electronic Audit Trail
- Part 11 Requirement Specifications
- Part 11 Compliance
- Using Computers in FDA Regulated Environments
- Implementing Part 11 (15 examples for pharma, devices and clinical studies)
- How to avoid Part 11 related 483's and Warning Letters
- How to respond to Part 11 related 483's and Warning Letters
- Implementing
Warning Letters and Inspectional Observations with typical deviations related to computer validation and Part 11 compliance
-:Risk based validation of software and computer systems
FDA Presentations:
- George Smith: CDER Part 11 Inspection Assignments (July 2010)
- Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
- Steve Wilson: FDA Regulatory Perspective on Data Integrity
Everybody using computers in FDA regulated environments
IT manager and staff
Order at any time, replay at any time, download the reference material at any time.
The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.
Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
Feedback: The seminar did exceed my expectations. The seminar is very useful as it contains a lot of information.
Mr. Lucian Hirtie, QS Manager, Labstat International ULC, Canada (Ref T-1082).
Feedback: The seminar did exceed my expectations. Very informative presentation, and clearly presented . Dr Huber does an excellent presentation, well developed, and very informative, as usual.
Mr. John Egoville, Senior Compliance Auditor, Computer Validation Group, TEVA Pharmaceuticals, USA (Ref T-1081)
Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
Feedback: The seminar did exceed my expectations. The presentation contains much more pertinent information than I had expected.
Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany (Ref T-1076).
Seminar: FDA's New Enforcement of 21 CFR Part 11
Feedback: The seminar did meet my expectations. I always expect a wonderful seminar from Dr. Huber, and my expectations were once again met. A great time saver for me as I do not have time to look up recent 483s relating to Part 11 -- worth the time and cost.
Ms. Diana Mayes, Manager of ABC Laboratories, USA (Ref T-1077).
Feedback: The seminar exceed my expectations. Webinar was very informative to our current practice and will help us focus and stream line our process. I would recommend this seminar to everyone having the same responsibilities.
Ms. Mike Robertson, QA Engineer at Energizer, USA (Ref T-1078).