Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard.
While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U.S. drug. API, and biologics process validation up to par with the advanced and modern expectations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics industries (or their vendors!) can afford to miss this presentation; while validation personnel in the medical device, tissue processing, and dietary supplement fields will find it informative and useful.
Why should you attend: FDA has stated that the principles in the new guidance are directly supported by regulation, law, and current best practices, and expects to begin issuing 483s immediately. While the medical device industry has been subject to many of the requirements in the new guidance, most pharmaceutical firms and their suppliers have not implemented, and may not even fully understand, the advanced statistical, scientific, and management expectations now demanded by FDA with the release of this standard.
Areas Covered in the Session:
* Specific discussions include
* Background of the original guidance, its history, application, and items covered
* FDA regulatory authority
* Growth of competing standards and the competing expectations of the medical device industry
* The history and philosophy of the new guidance
* The three stages of the new guidance, their sequence, and interrelationship
* Role of risk management, statistical controls, and GMP requirements
* Associated and predicate testing, qualifications, and vaildations
* Analytical and recordkeeping expectations
* Opportunity for accelerated release of commercial product
* Differences between the old and new standards, and the draft and final
Who Will Benefit:
* Validation specialist
* Validation engineer
* Process engineer
* Internal Auditors
* Validation manager
* Compliance manager
* Regulatory specialist
* Vendor Auditors
* Quality Engineer
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U.S. drug. API, and biologics process validation up to par with the advanced and modern expectations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics industries (or their vendors!) can afford to miss this presentation; while validation personnel in the medical device, tissue processing, and dietary supplement fields will find it informative and useful.
Why should you attend: FDA has stated that the principles in the new guidance are directly supported by regulation, law, and current best practices, and expects to begin issuing 483s immediately. While the medical device industry has been subject to many of the requirements in the new guidance, most pharmaceutical firms and their suppliers have not implemented, and may not even fully understand, the advanced statistical, scientific, and management expectations now demanded by FDA with the release of this standard.
Areas Covered in the Session:
* Specific discussions include
* Background of the original guidance, its history, application, and items covered
* FDA regulatory authority
* Growth of competing standards and the competing expectations of the medical device industry
* The history and philosophy of the new guidance
* The three stages of the new guidance, their sequence, and interrelationship
* Role of risk management, statistical controls, and GMP requirements
* Associated and predicate testing, qualifications, and vaildations
* Analytical and recordkeeping expectations
* Opportunity for accelerated release of commercial product
* Differences between the old and new standards, and the draft and final
Who Will Benefit:
* Validation specialist
* Validation engineer
* Process engineer
* Internal Auditors
* Validation manager
* Compliance manager
* Regulatory specialist
* Vendor Auditors
* Quality Engineer
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
