Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered.
Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution.
Areas Covered In the Session:
* Verification or Validation - Recent regulatory expectations
* The Master Validation Plan / structure
* Product Validation – how it differs from process / equipment V&V
* Process / Equipment / Facility Validation - FDA's new guidance
* When and How to use DQ, IQ, OQ, PQ, or their equivalents
* How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
* The 11 key documents for software validation
* Incorporating 21 CFR Part 11 requirements
* Suggested "test case" formats
Who will benefit:
* Senior management in Drugs, Devices, Biologics, Dietary Supplements
* QA
* RA
* R&D
* Engineering
* Production
* Operations
* Consultants; others tasked with product, process, software ... validation responsibilities
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered.
Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution.
Areas Covered In the Session:
* Verification or Validation - Recent regulatory expectations
* The Master Validation Plan / structure
* Product Validation – how it differs from process / equipment V&V
* Process / Equipment / Facility Validation - FDA's new guidance
* When and How to use DQ, IQ, OQ, PQ, or their equivalents
* How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
* The 11 key documents for software validation
* Incorporating 21 CFR Part 11 requirements
* Suggested "test case" formats
Who will benefit:
* Senior management in Drugs, Devices, Biologics, Dietary Supplements
* QA
* RA
* R&D
* Engineering
* Production
* Operations
* Consultants; others tasked with product, process, software ... validation responsibilities
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
