GMP Vendor Audits

Duration: 60 Minutes
Description of a method to establish and conduct GMP audits of vendor facilities.
Vendor Audit Good Practices
Instructor: Dr. James R Harris
Product ID: 500056
We expect that the goods purchased from third party suppliers will be of consistent quality and will help our products in which they are used at the expected quality level. A problem with this, however, is that slight changes in the vendor's process or procedures may not only violate the GMPs but also affect the quality of the products we manufacture. All too often, these changes will not be detected in the purchaser's incoming quality testing. Vendor audits are an excellent method of stressing your value and expectations on quality as well as helping reinforce your standards.

Why Should you Attend:
It is important to get the most value from the vendor audits you conduct. This presentation will help reinforce your quality standards with your vendors. It also presents a method to assure that all of the critical factors involved will be audited and that the audit will be conducted quickly and efficiently.

Objectives of the Presentation:
  • How to determine who should be audited
  • How to determine audit frequency
  • Learn how to prepare for an audit
  • Learn how to prepare an audit checklist
  • Learn how to conduct the audit
  • Follow-up procedures
Who can Benefit:
Quality Assurance and manufacturing managers and any personnel who are involved in vendor audits will benefit by learning a simple and effective method of conducting audits that will provide assurance of quality in the products being purchased.

Live Session - How it works
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  • Get certification of attendance.
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  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
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$375
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA. While consulting, he and his consulting teams have assisted numerous clients around the world with validation of their manufacturing processes. Dr. Harris played a vital role in establishing many of the regulations in existence today, with particular emphasis on validation of all types.
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