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GMP Auditing for Pharmaceutical Manufacturing
 
 
Carl Patterson

Carl Patterson, M.S. is Keynote Speaker at Compliance key Inc. 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 comple

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Overview
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:
  • Preparing for a vendor audit and implementing a scientific risk based 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.
 
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.
 
Product Id : LSHCGCP002
Training Options                        Duration: 60 mins
06/26/2017  10:00 AM PST | 01:00 PM EST
Single Attendee:   [Only for one participant]
Price: $165 (Live) Price: $270 (Live + Recorded)
Multiple Attendee:   [For a group of 2 to 5 participants]
Price: $335 (Live) Price: $440 (Live + Recorded)
Corporate Attendee:   [For a group of 6 - 10 Participants]
Price: $670 (Live) Price: $775 (Live + Recorded)
Recorded   [Six month unlimited access]
Price: $193
     Refund Policy
 
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