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.
Who Should Attend:
This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation.
The employees who will benefit include:
- Senior and middle management and staff
- Regulatory Affairs
- Quality Assurance or Quality Control Professionals
- Production Management
- Manufacturing Engineers
- Process Engineers
- Software Engineers
- Project Managers
- Hardware and software vendors, sales and marketing
- Any professional tasked with V&V responsibilities
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/j7l8cs/verification_vs