Event Type:
Educational Conference

Event Topic/Title:
PDA Technical Report No. 1, Revised 2007, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control and “Summary of the PDA Risk Management and Aseptic Processing
Conference held in May 2008 – updates of TR#22 and TR#44 Task Forces”

Speaker(s):
Mr. Kristen D. Evans and Mr. Martin G. VanTrieste from Amgen

Speaker Bio:
Mr. Kristen D. Evans – currently Director of Global Quality Compliance at Amgen, Inc. Previously, a Senior Regulatory Compliance Officer for CDER, FDA. He retired from the agency after serving for 20 years in roles including: CDER Subject, Contact in the areas of sterilization, facility and equipment design/control, and validation, Project leader to redraft the FDA Compliance Policy Guide regarding parametric release of terminally sterilized products, Project leader to redraft the FDA Compliance Program Guidance Manual for Inspections of Sterile Drug Processes, involved in the development of the Pharmaceutical Inspectorate (PI) and other technical tasks within CDER.

Mr. Martin G. VanTrieste is a Vice-President for Commercial Quality at Amgen, Inc. Prior to joining Amgen, Martin was with Bayer HealthCare’s Biological Products Division as vice president of Worldwide Quality and Abbott Laboratories as the vice president of Quality Assurance for the Hospital Products Division (now known as Hospira). He is a member of the PDA Board of Directors and co-chair of the Science and Technology Advisory Board.

Location:
Condado Plaza Hotel and Casino, 999 Ashford Ave., San Juan, P.R.
Time: 4:00PM – 9:00PM

Event Abstract:
Kris Evans, a member of the PDA Task Force on Technical Report No. 1, will discuss the recommendations in the 2007 revision. The product of new contributions and original text revisions by 40 contributors with scientific and regulatory backgrounds, the 2007 revision of Technical Report No. 1 contains consensus scientific guidance and recommendations on how to establish a moist heat sterilization program that may be applied globally.

Martin VanTrieste will summarize the discussions held during the May PDA Conference on Aseptic Processing Risk Management. The conference included discussions on: Aseptic Risk Assessment modeling alternatives, regulatory expectations for Aseptic Processing Risk Evaluations, technology assessment and emerging technologies for Aseptic processing.

Price:
$90/pp (members), $125/pp (non-members) – Networking Reception included