21 CFR Part 11 compliance under the Obama administration
Instructor:
Alfonso Fuller
Product ID: 701215
- Duration: 60 Min
FDA’s Electronic Records and Electronic Signatures regulation (21 CFR Part 11) became effective in 1997 and was not heavily enforced by the Bush Administration. Top FDA officials including the Commissioner, Deputy Commissioner and other officials have resigned in the face of President Obama’s inauguration, and the new President is widely expected to beef up FDA authority and enforcement of existing regulations. This presentation will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.
Areas Covered in the seminar:
- Intermediate-Level review of current status of 21 CFR Part 11.
- What is the relationship between "validation" and "part 11 compliance".
- What do I have to do today to be in compliance?
- What changes can I expect to see in Part 11?
- When will part 11 change?
- What is the future part 11 likely to look like?
- How can I best integrate part 11 compliance into my quality system?
- How can I ensure what I do today will stand inspection tomorrow?
Who will benefit:
Companies that manufacture, sell, or distribute Pharmaceuticals, Medical Devices or Biologics will benefit from this webinar, as well as vendors and suppliers who support them. Personnel who will benefit include:
- Management responsible for operational and quality systems ("system owners")
- Vice Presidents, Directors, Managers and other Quality personnel
- IT / IS managers and personnel
- Software validation and software quality managers + personnel
- Consultants charged with creating or evaluating part 11 programs
- Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
- Quality auditors responsible for auditing and evaluating part 11 compliance
Alfonso Fuller, Esq. is the attorney-founder and President of Fuller Compliance, LLC, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of numerous white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel.
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