GMP Auditing for Pharmaceutical Manufacturing.

Carl Patterson, M.S. is Keynote Speaker at ComplianceKey. He has completed twelve (12) plus years in the biotechnology, pharmaceutical manufacturing, and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, relate........


Auditing involves a comprehensive review of vendors that will provide resources and/or services. The ICH Q10 document provides an outline on the pharmaceutical drug product life-cycle. Through the review of ICH Q8, Q9, and Q10, the participant will be able to audit the various activities associated with the different stages of the product lifecycle. By using a scientific risk-based approach, as outlined in ICH Q9, the participant will be able to mitigate risk associated with the product during the various stages of the product lifecycle. This approach can be used to further understand the quality aspects of the product; therefore giving regulatory bodies confidence in the product being manufactured.

Why should you attend this webinar?

Auditing vendors of products and or services is a crucial cGMP requirement in the lifecycle of the product. Virtual companies are required to audit and are ultimately responsible for the product and the quality of the product throughout its entire lifecycle. By understanding the risk management concepts in ICH Q9, personnel will be able to determine the aspects of the product lifecycle that need to be scrutinized more closely based on the amount of risk associated with the product.

Areas Covered in the Session:

Who can Benefit:

New QA personnel involved with auditing for virtual companies. Personnel introduced to auditing, subject matter experts, who may accompany QA personnel and/or conduct audits. Management personnel who wish to understand the auditing process.

Webinar Id: LSHCGCP005

Training Options:

Duration: 60 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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