Parenteral Drug Association

2010 PDA/FDA Joint Regulatory Conference
September 13-16, 2010 | Washington, D.C.

PDA’s Universe of Pre-filled Syringes and Injection Devices
October 18-21, 2010 | Las Vegas, Nevada | Register before July 27th and Save $400!

Parenterals 2010: Integrating Process, Technology and Regulation
October 26-28, 2010 | Berlin, Germany | Register early and save!!

Laboratory Design: Establishing the Facility and Management Structure
Pre-order before August 15th and save 10%

Upcoming PDA Web Seminars
Topics Include: Virus Clearance, Current Perspectives in Biofilms Growth and Automated Validation Lifecycle Management – A Working Model

Deadline August 13th: Take Our Survey and Help PDA Europe Improve Their Conference Offerings to You!
By participating in our brief survey you will make a substantial contribution to the development of new topic areas so that PDA can better meet your future needs. The information that you provide will be held in confidence and will not be publicly reported with your name or affiliation.
Blow/Fill/Seal Interest Group Session – At the PDA 2010 PDA/FDA Joint Regulatory Conference
If you are planning on attending the PDA 2010 PDA/FDA Joint Regulatory Conference, you are invited to participate in our first Blow/Fill/Seal Interest Group session. This newly formed Interest Group is led by Stefan Kohler, Director of Manufacturing, Sterile, and Aseptic Technology, AstraZeneca Sweden Operations. The Interest Group session will address a variety of topics relevant to Blow/Fill/Seal Technology in the venues of Manufacturing and Technology, Research, Quality, Scientific and Regulatory, and Validation.
PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop
(December 1-3, 2010 in Bethesda, Maryland) This workshop has been developed to address current viral contamination events and is intended to encourage modernization in industry with respect to viral detection and control measures. Gaps in our current ability to detect, control and clear adventitious viruses; the availability of emerging technologies in areas where gaps exist; and CGMP expectations for adventitious virus detection and control, as well as consequences for noncompliance will be discussed.
2011 PDA Annual Meeting Call for Papers/Abstracts
The 2011 PDA Annual Meeting will explore an area of immense importance to our industry – Harnessing the Power of Knowledge to Drive World Class Science and Technology. The Program Planning Committee invites you to submit an abstract for presentation at this meeting by July 30, 2010.
ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10
USA: 6-8 October 2010 Washington, DC
Japan: 25-27, October 2010 Tokyo

Practical training on integrated implementation of Q8, Q9 and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and GMP-inspection. This is an opportunity for open dialogue among industry and regulators on: Comprehensive training on regulatory aspects, technical development and manufacturing, case study combining Q8, Q9 and Q10 and regulatory topics related to submission expectations and GMP-inspections.

Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection
Author: Jeanne Moldenhauer

Environmental Monitoring A Comprehensive Handbook, Volume 4
Edited by Jeanne Moldenhauer

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