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Subscribe NewsletterProcess Verification / Validation Under HACCP, the cGMPS and ISO
Product Id
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600178
Overview: FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
A major problem area is lack of defined or integrated risk-based verification and validation of an entire process - equipment, cleaning / maintenance, testing -- including consideration of its Critical Control Points and their monitoring. Regulatory expectations now incorporates product risk management, eg., ISO 14971 and ICH Q9. This webinar will address when DQs, IQs, OQs, and PQs are required. It will also evaluate requirements for process software validation with a brief consideration of the QMS interface and 21 CFR Part 11, Electronic Records / Electronic Signatures issues. Some viable models, accepted by the FDA, will be considered.
A major problem area is lack of defined or integrated risk-based verification and validation of an entire process - equipment, cleaning / maintenance, testing -- including consideration of its Critical Control Points and their monitoring. Regulatory expectations now incorporates product risk management, eg., ISO 14971 and ICH Q9. This webinar will address when DQs, IQs, OQs, and PQs are required. It will also evaluate requirements for process software validation with a brief consideration of the QMS interface and 21 CFR Part 11, Electronic Records / Electronic Signatures issues. Some viable models, accepted by the FDA, will be considered.
Areas Covered in the Session:
- Verification or Validation – heightened regulatory expectations
- The Process Validation Plan
- HACCP
- Process Inputs and Process Mapping Tools
- Process (and Equipment) Validation Files / Protocols
- When and how to use DQ, IQ, OQ and PQs
- Using your Risk Management File / Report when resource constrained
- Test case suggestions
- Re-validations
Who Will Benefit:
- Senior management, project leaders
- Internal / external auditors and/or consultants
- Regulatory affairs
- Quality systems personnel / QAE
- New product development, Marketing and R&D
- Product and manufacturing engineering staff
- Document control