This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.
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"This course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1 RAC Points up on full
completion of the course."
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Why Should You Attend:
FDA is increasing emphasis on scrutiny of computer systems validation and adherence of 21 CFR part 11 compliance by all companies. Most of the recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations with respect to improper or ineffective validation. Increasing use of automated manufacturing and quality system is forcing exposure of computer systems. On the other hand Software Quality, Validation and Compliance personnel often cannot explain in technical detail how to comply and often find it difficult to translate business requirements into technical design where as FDA inspectors are now being trained to evaluate software validation practices.
As compliance pressure rises, programmers, developers and system maintenance personnel need to determine exactly how to ensure 21 CFR part 11 compliance. Technical personnel need to understand how to weave part 11 compliance into computer systems regulated by FDA. This presentation will provide "under-the-hood' technical details of what is required and how to provide it.
Areas Covered in the seminar:
- Outline of FDA regulatory scheme.
- Review of FDA software validation regulations.
- Why 21 CFR part 11 compliance is good business.
- Review part 11 regulation.
- Future of part 11 enforcement.
- The biggest 21 CFR part 11 technical problems.
- Communicating part 11 technical details with business, validation and software quality assurance.
Who will benefit:
This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:
- Technical implementation personnel
- Technical maintenance personnel
- System designers and integrators
- System owners - responsible for keeping individual systems in validation
- QA / QC managers, executives and personnel
- Consultants
- IT / IS managers and personnel
Instructor Profile:
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, and actively consults on day-to-day compliance issues.
