GMP Quality Principles

Duration: 60 Minutes
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.
GMP Quality Principles
Instructor: Dr. James R Harris
Product ID: 500087
On the internet, this portion of the CFR occupies 23 double column pages of fine print. While every practitioner in the pharmaceutical manufacturing and quality management business needs to have a copy of this information available when a specific question arises, for every day management and control of the GMP regulations a solid understanding of the GMP Quality Principles is more useful and can be the basis for assuring cGMP compliance.

Why Should you Attend:
Stories of problems encountered by pharmaceutical manufacturers who are found to fail FDA inspections and subsequent follow-ups are known to everyone in the industry. Manufacturing facilities have been closed pending changes needed to achieve full compliance and fines of $500,000,000 have been assessed. A solid knowledge of the principles of GMP Quality standards can be your day-to-day guideline for creating and maintaining full compliance with the GMP regulations.

Full compliance must be a top objective of everyone in this industry. The big question for most of us is how to achieve this necessary goal and still have time to complete our assigned responsibilities. To accomplish this, we have analyzed the GMP regulations and summarized them in a few basic GMP Quality Principles. Knowledge and use of these principles will not eliminate the need to have a copy of the regulations for reference, but it will answer most questions quickly and effectively.

Learning objectives:
Learning about the role and responsibilities of an efficient and effective GMP proponent and developing a solid understanding of the GMP regulations.

Objectives of the Presentation:
  • Responsibility of the Quality Control Unit
  • Required qualities of buildings & facilities
  • Equipment
  • Control of components and drug product containers
  • Process controls
  • Packaging and Labeling
  • Warehousing and Distribution
  • Laboratory controls
  • Records and Reports
  • Returned and Salvaged product
Who can Benefit: This webinar will provide valuable assistance to all personnel in:
  • Personnel interested in exploring the fields of pharmaceutical manufacturing
  • New pharmaceutical manufacturing and quality supervisors and managers
  • Administrative managers in charge of pharmaceutical manufacturing or quality
  • Pharmaceutical manufacturing and quality Associates and Manager
$375
Recorded Session for one participant
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Live Session - How it works
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  • 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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