Equipment Qualification and Process Validation

Instructor: Loren Gelber
Product ID: 705853
Training Level: Intermediate
  • Duration: 90 Min
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 made and periodically as necessary.
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Read Frequently Asked Questions

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. When sampling after a step will not provide accurate information (e.g. some blend uniformity test results) will be considered.

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.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Personnel responsible for equipment qualification
  • Personnel responsible for computer system qualification
  • Personnel responsible for manufacturing process validation
  • Regulatory Affairs, Regulatory Compliance
  • Quality
Instructor Profile:
Loren Gelber

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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