Equipment Qualification and Process Validation

Duration: 90 Minutes
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This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to tests) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes to be validated if problems are encountered changes have to be made periodically as necessary.
Equipment Qualification and Process Validation
Instructor: Loren Gelber
Product ID: 504089
Objectives of the Presentation
  • General FDA GMP information re qualification and validation
  • Equipment Qualification
    • IQ
    • OQ
    • PQ
  • Computer System Qualification and Part 11
  • Manufacturing Process Validation
    • Specifications
    • When to test
    • What to test
    • How much to test
Why Should you Attend
Lack of qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and process validation will benefit from a review of the relevant FDA rules, written and unwritten.

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes validated.

Equipment qualification includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). All three will be discussed and examples from both manufacturing and laboratory equipment will be provided. Retrospective qualification of previously unqualified equipment already in place will be considered. Qualification of computer systems will also be presented.

Process validation involves proof that each step of a manufacturing process does what it is supposed to do. The degree of proof required will be discussed. These equipment qualifications and process validations must be repeated if changes are made or if problems are encountered, and periodically as necessary. How often to revalidate will be discussed. Attend this webinar to understand each of the above process for equipment qualification & steps for process validation of FDA cGMP regulations.

Who will Benefit
This course is designed for people tasked with developing, maintaining and/or improving equipment qualification programs for manufacturing facilities. This includes individuals that have quality management systems responsibilities for making general improvements in their organization's performance specifically related to equipment and processes. Following personnel will benefit from the course:
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Validation engineers
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
$230
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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
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  • 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. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.
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