Key Take Away:
This webinar will provide an understanding on the guidance outlined in ICH Q10 as it pertains to the lifecycle of the pharmaceutical product. From this approach, you will understand which aspects to focus on during audit procedures of various activities related to the product.
Overview:
Internal audit 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.
Why Should You Attend:
Audit process of 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 assessment 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 quality risk management associated with the product.
Areas Covered In This Webinar:
Preparing for a vendor audit and implementing a scientific risk analysis prior to conducting the audit is crucial in understanding the aspects of the product being manufactured.
Based on the risk assessment, a determination of how much due diligence would be required. Either through a self-assessment checklist, an on-site audit, or other methods to qualify the vendor, the participant will understand the steps under which the vendor may be considered qualified.
Quality risk management will be discussed and how it is implemented in the auditing process. Once a vendor audit is completed, the participant will be able to employ, with the help of the vendor, proper audit closing techniques to ensure the quality aspects of the product.
Learning Objectives:
• Review of ICH guidelines Q8, Q9, and Q10, to be able to audit the various activities associated with the different stages of the product lifecycle
• Mitigate risk associated with the product during the various stages of the product lifecycle
• Understand the quality aspects of the product; giving regulatory bodies confidence in the product being manufactured
Who Will 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
For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/pharmaceuticals/auditing-for-the-pharmaceutical-industry/carl-patterson/300132
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Level:
Beginner
Speakers Profile:
Carl Patterson
Carl Patterson, M.S. has completed twelve 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, environmental monitoring, and quality systems. He has helped to insure the expectations, related to quality systems, have been met.
