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Catalent Quality Expert Invited to Discuss Effective Auditing Strategies at Upcoming PDA/FDA Joint Regulatory Conference
  • USA - English


News provided by

Catalent Pharma Solutions

Sep 28, 2015, 09:00 ET

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(PRWEB) September 28, 2015 -- Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that Scott Gunther, Vice President of Quality, Advanced Delivery Technologies, will participate at the upcoming 2015 PDA/FDA Joint Regulatory Conference, to be held at the Renaissance Washington DC Hotel, on September 28th – 30th, 2015.

Mr. Gunther has been invited to speak in the Q&A panel discussion of Session B1, “Effective Corporate Auditing Programs”, on Monday September 28th, 2015 between 2:15 p.m. – 2:45 p.m. The session sees a number of speakers discuss the need to establish an effective auditing program for suppliers, to identify crucial noncompliant issues before they manifest into serious compliance concerns. These events may result in lost manufacturing time or cessation of manufacturing operations, leading to potential drug shortages. An overview of the audit process from the perspectives of both the auditor (client) and auditee (contract provider), will be given to demonstrate how both must be flexible in order to ensure a successful audit outcome.

Scott Gunther joined Catalent in 2012 as Vice President, Quality, and is responsible for all quality operations covering the Modified Release Technology Business Unit within the company. Previously he has held positions at Bristol Myers Squibb, including Executive Director Quality Operations Americas, where he was responsible for quality operations covering the United States, Puerto Rico, and Latin America. He holds a BS in Industrial Technology from the State University of New York College, Buffalo, and a MBA from Canisius College.

For more information on the 2015 PDA/FDA Joint Regulatory Conference Conference, visit: http://www.pda.org/conference/2015-pda-fda-joint-regulatory-conference/home and to arrange a meeting with Mr. Gunther, contact Richard Kerns at NEPR- richard(at)nepr(dot)eu

About Catalent
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,700 people, including over 1,000 scientists, at 31 facilities across 5 continents, and in fiscal 2015 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit http://www.catalent.com

More products. Better treatments. Reliably supplied.™

Chris Halling, Catalent Pharma Solutions, http://www.catalent.com, +44 7580041073, [email protected]

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