Internal GMP Audits

Duration: 60 Minutes
This presentation provides a complete system for conducting internal GMP audits. It covers what to do and what not to do in performing internal audits for the purpose of assuring full compliance with the GMP regulations.
Pharma GMP audit
Instructor: Dr. James R Harris
Product ID: 500048
When FDA audits a firm, they are primarily checking to determine how well the facility complies with the GMP requirements. Prudence requires a facility to regularly check themselves for compliance so they can be certain that nothing has slipped in that may adversely affect the quality of the products they produce. Internal audits are the best way to accomplish this goal.

Why Should you Attend:
Like the audit itself, it is simply good business to review and analyze their internal procedures to assure continued high levels of operation. This presentation will assist newcomers in creating their internal audit system and will provide insight for others to re-evaluate their current audit system.

Objectives of the Presentation:
To provide a comprehensive internal audit process with ideas that will challenge the system your firm uses.

Who can Benefit:
  • QA managers and personnel who conduct GMP audits as well as managers of all areas that could be audited.
Recorded Session - How it works
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$375
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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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