21 CFR Part 11 Compliance for Computer Systems Regulated by FDA ( Code:   )



Director:

  Dates:
8 Mar - 9 Mar 2020

 Location:
Los Angeles, CA, USA

 Download:
Seminar Brochure

The Seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).SEM9004

Peter Vishton

Peter is an Independent Pharmaceutical Water Systems Consultant working with several companies. He has 25 years of experience in the Pharmaceutical area which includes 10 years with Pharmaceutical Water Systems.

Peter’s experience includes being a member of GMP Teams to Design / Construct / Start Up /Commission and Qualify new or expanded pharmaceutical facilities. These were GMP Production spaces, Manufacturing Equipment, Utilities and their Control Systems. Among the assignments were Parenterals, Biologics, OSD and their Pharmaceutical production rooms and equipment. The utilities and facilities Validation documentation were included and lead to the completion of Validation and initial production batches.

Peter completed his Bachelor’s Degree and his Master of Environmental Management Degree from Drexel University. He is an active ISPE member that participates in current and new technology publications and forums assuring current knowledge of industry practices in GMP Manufacturing, Clean Utilities, Quality and FDA guidance. He has been a contributing author on all the ISPE Communities of Practice Publications for GMP Pharmaceutical Water, Steam and Compressed Gasses where he worked with Industry Experts.

Lecture 1:

– “GxP” Computer Systems and FDA Oversight
Lecture 2:

– Computer System Validation (CSV)
Lecture 3:

– System Development Life Cycle Management (SDLC) Methodology
Lecture 4:

– FDA’s 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance

Lecture 1:

– Strategic Approach to ER/ES Compliance
Lecture 2:

– Policies and Procedures to Support GxP Compliance with 21 CFR Part 11
Lecture 3:

– Training and Organizational Change Management Best Practices
Lecture 4:

– Industry Best Practices and Common Pitfall

Los Angeles, CA, USA

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The Seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).SEM9004

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