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.
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.
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
Course Provider
Joy McElroy,
