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Dr. James R Harris
President, Principal Consultant,
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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This presentation outlines the contents of the FDA's Industry Guidance draft document titled Contract Manufacturing Arrangements for Drugs: Quality Agreements issued in May of 2013. While this was issued as a draft document, we know that while there may be some changes in wording, this Guidance Document is notification of FDA thinking and will be enforced as a cGMP document.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This presentation reveals the recent cGMP citations and discusses what could have been done to prevent them. By learning these two fundamentals and establishing a proactive program of compliance, any pharmaceutical manufacturer can avoid serious cGMP citations.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

This presentation covers a methodology that can be used for any oral product process validation
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing, Processing, Packing, or Holding of Drugs.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

Description of a method to establish and conduct GMP audits of vendor facilities.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.