ComplianceOnline

Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Instructor: Dr. Ludwig Huber
Product ID: 701547
  • Duration: 75 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

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Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.

Why Should You Attend:

Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative, FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the guidance from 2003. In the meantime, FDA officials reported key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.

Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.


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Hand-outs:

For easy implementation, attendees will receive:

  • Checklist: Part 11 compliance
  • Case studies: How to avoid Part 11 related 483s and Warning Letters
  • SOP: Electronic audit trail - specifications, implementation, validation

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 Webinar:

  • 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 and authenticity: FDA's new focus during inspections
  • Examples of recent Part 11 related 483s and Warning Letters
  • Examples of recent 483s and Warning Letters related to computer system validation
  • Most obvious reasons for deviations
  • Avoiding and responding to 483s: going through case studies
  • Writing corrective and preventive action plans as follow up to 483s
  • Using internal audits to prepare yourself for Part 11 related FDA inspections
  • Strategies and tools for compliant Part 11 implementation
  • The future of Part 11 and computer system validation

Who Will Benefit:

  • Personnel from the pharmaceutical and medical device industry
  • Manufacturers of drug substances (APIs)
  • Contract laboratory staff
  • Employees using computers in FDA regulated environments
  • IT managers and staff
  • QA managers and personnel
  • Quality control directors or delegates
  • Regulatory affairs personnel
  • Training department personnel
  • Consultants
  • Validation specialists
Instructor Profile:
Dr. Ludwig Huber

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

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 and validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.

Follow us :
ComplianceOnline Medical Device Summit 2017
FDA's New Import Program for 2017 - Strict Precision

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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