DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Verification vs. Validation - Product Process Software and QMS" conference to their offering.
This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.
This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources.
It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions.
- Lecture 1: Master Validation Planning and the Master Validation Plan(s)
- Lecture 2: Product, Process / Equipment Hardware V&V
- Lecture 3: Product / Device V&V
- Lecture 4: Software V&V
- Lecture 5: Quality Management System / 21 CFR Part 11 V&V
- Lecture 6: Summary of morning discussion
- Lecture 7: Group activity on the MVPs
- Lecture 8: Review of group activity and Q&A
- Lecture 1: Software V&V documentation "model"
- Lecture 2: Software V&V protocols - "black box", "white box"
- Lecture 3: Electronic Records and Electronic Signatures (Part 11)
- Lecture 4: Summary of morning discussion
- Lecture 5: Group activity on 1) hardware / equipment, and 2) software V&V protocols
- Lecture 6: Review of group activity and Q&A
- Lecture 7: Course summary discussion
- Lecture 8: Summary of morning discussion
- Lecture 9: Group activity on the MVPs
- Lecture 10: Review of group activity and Q&A
For more information about this conference visit http://www.researchandmarkets.com/research/mk9cqq/verification_vs
Related Topics: Production and Quality Management