PDA Education to Offer FDA CDER Five Specialized Courses on Sterilization and Media Fills 12 August, 2016

Bethesda, Md., August 12, 2016 – The Parenteral Drug Association (PDA) Education—Where Excellence Begins—announces the development of five specialized courses for officials in the U.S. FDA’s Center for Drug Evaluation and Research, commencing in September and running through early 2017. The lecture courses will take place at FDA’s White Oak Campus, Silver Spring, Maryland.

The series of courses covering steam sterilization, sterile filtration and media fills will be taught by expert faculty from the industry. The courses are:

September 9, 2016
Basics of Steam Sterilization
Mike Sadowski, Director, R&D Sterility Assurance, Baxter International Inc.

October 7, 2016
Advanced Steam Sterilization   
Mike Sadowski, Director,  R&D Sterility Assurance, Baxter International Inc.

November 8, 2016
Media Fills
Harold Baseman, Chief Operating Officer and Principal, ValSource LLC 

January 10, 2017
Container Closure Systems and Integrity Testing
Lei Li, PhD, Sr. Consultant Engineer, Delivery and Device R&D, Eli Lilly and Company

February 7, 2017
Sterilizing Filtration
Maik Jornitz, President, G-CON Manufacturing Inc.
Wayne Garafola, Field Applications Specialist - Filtration Technologies,
Sartorius Stedim North America Inc.

The training is the latest example of PDA’s long history of providing expert training to regulators worldwide. The FDA has regularly participated in specialized training for aseptic processing techniques and sterilization since PDA opened the Training and Research Institute in 1997. PDA also has conducted inspectorate training with European regulators and in recent years has partnered with the cross-inspectorate organization Pharmaceutical Inspection Convention/Scheme to provide regulatory training on topics like data integrity.

About PDA Education – Where Excellence Begins

Built on a reputation of excellence and founded in science, PDA Education courses provide new and experienced professionals alike with practical information and implementable solutions related to essential industry topics.