2009 PDA/FDA Joint Regulatory Conference Course Series

2009 PDA/FDA Joint Regulatory Conference

Fri, 01 May 2009 12:42:10 GMT

N/A

Quality by Design for Biopharmaceuticals: Concepts and Implementation - New Course

Thu, 05 Mar 2009 13:19:11 GMT

September 17, 2009
Patrick Swann, PhD, Deputy Director, Division of Monoclonal Antibodies, OBP-OPS-CDER, FDA, and Anurag Rathore, PhD, Process Development, Amgen, Inc., will aim to clarify the key concepts that interplay in defining and implementing QbD towards manufacturing of biotech products.

Process Validation for Pharmaceuticals: Current and Future Trends

Tue, 21 Oct 2008 14:13:08 GMT

September 17, 2009
Scott Bozzone, PhD, Sr. Manager of Global Quality Operations - Validation, Pfizer, Inc.

GMP for Clinical Trial Materials: Regulations and Applications

Mon, 20 Oct 2008 14:26:14 GMT

September 17, 2009
This course will review the regulatory background associated with the manufacture of clinical trial materials, including FDA Guidance on the topic, and will also consider and discuss examples of how the regulations might be applied to the special situation of clinical trial material manufacture.
Robert Dana, PDA
Vince Mathews, Eli Lilly and Co.

Risk Management in Aseptic Processing

Mon, 20 Oct 2008 13:53:04 GMT

September 17, 2008
This course will provide the attendee with a background in risk management and aseptic process concepts, definitions, and regulatory expectations; as well as method for assessing, evaluating, controlling and communicating risk and related aspects of risk management.
Hal Baseman, ValSource, LLC

Developing a Robust Supplier Control Process

Mon, 20 Oct 2008 10:23:43 GMT

September 17, 2009
This workshop will discuss best methods for determining appropriate level of control for suppliers based on risk and developing assessment methods and continous monitoring tools.
Lisa Hornback, Hornback Consulting, LLC

Qualification and Validation of API Manufacturing Operations

Mon, 20 Oct 2008 15:17:01 GMT

September 17-18, 2009
This is an in-depth one and one-half day workshop designed to give the participant a thorough foundation in the qualification and validation of all operations related to the production of Active Pharmaceutical Ingredients.
Daniel Gold, PhD, D.H. Gold Associates

Preparing for Regulatory Inspections for the FDA and EMEA

Mon, 20 Oct 2008 14:53:05 GMT

September 17-18, 2009
The objective of this one and one-half day lecture course is to assist participants in the preparation to host an inspection, primarily focusing on EMEA GMP or pre-approval site inspections.
David Chesney, PAREXEL Consulting

Contact

Fri, 13 Mar 2009 08:59:52 GMT

Stephanie Ko
PDA Training and Research Institute
Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Location

Fri, 13 Mar 2009 09:02:12 GMT

Renaissance Hotel
999 9th Street, NW
Washington, D.C. 20001
+1 (202) 898-9000