Article by Howard Cooper

Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP’s

Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.

During this webinar, the present status of these Guidances will be discussed and suggestions for their implementation will be presented. This webinar will be very informative for Quality Assurance personnel who have the desire to move toward implementing quality concepts rather than focusing on the strict rules of compliance. This webinar will show how to strike a balance between compliance and quality.

Areas Covered In the Session:

* What are the objectives of ICH-Q10 and the FDA’s Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really “Compliance in Sheep’s Clothing? * Who will win the GMP battle-Quality or Compliance

Who Will Benefit:

* Quality Unit Supervisors/Managers/Directors * Manufacturing Supervisors/Managers/Directors * Support Functions to Quality or Manufacturing * Regulatory Affairs personnel responsible for GMP Compliance and filings * Support personnel responsible for GMP Related activities such as Calibration and Testing Functions * Validation personnel * R&D Professional, Supervision and Management

Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP’s

Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.

During this webinar, the present status of these Guidances will be discussed and suggestions for their implementation will be presented. This webinar will be very informative for Quality Assurance personnel who have the desire to move toward implementing quality concepts rather than focusing on the strict rules of compliance. This webinar will show how to strike a balance between compliance and quality.

Areas Covered In the Session:

* What are the objectives of ICH-Q10 and the FDA’s Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really “Compliance in Sheep’s Clothing? * Who will win the GMP battle-Quality or Compliance

Who Will Benefit:

* Quality Unit Supervisors/Managers/Directors * Manufacturing Supervisors/Managers/Directors * Support Functions to Quality or Manufacturing * Regulatory Affairs personnel responsible for GMP Compliance and filings * Support personnel responsible for GMP Related activities such as Calibration and Testing Functions * Validation personnel * R&D Professional, Supervision and Management

Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP’s

Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.

During this webinar, the present status of these Guidances will be discussed and suggestions for their implementation will be presented. This webinar will be very informative for Quality Assurance personnel who have the desire to move toward implementing quality concepts rather than focusing on the strict rules of compliance. This webinar will show how to strike a balance between compliance and quality.

Areas Covered In the Session:

* What are the objectives of ICH-Q10 and the FDA’s Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really “Compliance in Sheep’s Clothing? * Who will win the GMP battle-Quality or Compliance

Who Will Benefit:

* Quality Unit Supervisors/Managers/Directors * Manufacturing Supervisors/Managers/Directors * Support Functions to Quality or Manufacturing * Regulatory Affairs personnel responsible for GMP Compliance and filings * Support personnel responsible for GMP Related activities such as Calibration and Testing Functions * Validation personnel * R&D Professional, Supervision and Management

About the Author

Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices.

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