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Subscribe NewsletterMaster Verification and Validation Planning Under the cGMPS and ISO 13485
Product Id
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600180
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 risk-based verification and validation comprehensive planning, defined and documented. Regulatory expectations now include a corporate and site Master Plan, which needs to incorporate product risk management, eg., ISO 14971:2007 (Devices) and ICH Q9 (Pharma). This webinar will address: Product, Process / Equipment, and QMS V&V; when DQs, IQs, OQs, and PQs are required; how does software validation for product, process or QMS / 21 CFR Part 11 differ. A suggested matrix is provided. Some viable models, accepted by the FDA, will be considered.
A major problem area is lack of defined risk-based verification and validation comprehensive planning, defined and documented. Regulatory expectations now include a corporate and site Master Plan, which needs to incorporate product risk management, eg., ISO 14971:2007 (Devices) and ICH Q9 (Pharma). This webinar will address: Product, Process / Equipment, and QMS V&V; when DQs, IQs, OQs, and PQs are required; how does software validation for product, process or QMS / 21 CFR Part 11 differ. A suggested matrix is provided. Some viable models, accepted by the FDA, will be considered.
Areas Covered in the Session:
- Verification or Validation - heightened regulatory expectations
- The Master Validation Plan
- Product, Process and Equipment Validation – differences
- When and how to use DQ, IQ, OQ and PQs
- Use the Risk Management File / Report for resource constraints
- 11 "must have' elements of software V&V
- Software "white box" and "black box" validations
- Risk-based test case suggestions
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