Objectives of the Presentation
Why Should you Attend
- General FDA GMP information re qualification and validation
- Equipment Qualification
- Computer System Qualification and Part 11
- Manufacturing Process Validation
- When to test
- What to test
- How much to test
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.
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.
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
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.