Scientific and Regulatory Affairs

• PDA’s Quality Culture team has developed an assessment tool specific to the pharmaceutical industry that can be used for internal assessment and audits of pharmaceutical suppliers and contract manufacturing organizations. The team is looking for manufacturing sites to help test out the tool. For more information and to volunteer, contact PDA Lead Denyse Baker or PDA Quality Culture Team Lead Cylia Chen. 
• In April 2016, the Subcommittee for Advanced Manufacturing of the National Science and Technology Council published a report that captured technology areas in advanced manufacturing that are current priorities for the Federal Government and are strong candidates for focused Federal investment and public-private collaboration. Emerging technology areas include advanced materials manufacturing, engineering biology to advance biomanufacturing, biomanufacturing for regenerative medicine, advanced bioproducts manufacturing and continuous manufacturing of pharmaceuticals. Read more.
• The U.S. FDA is working on strengthening its protection of pharmaceutical data submitted in regulatory filings during the approval process of new drugs. According to the Agency’s 2015-2018 Information Technology Strategic Plan, the U.S. FDA will implement independent verification and validation for high‐risk systems, move to a next‐generation network security architecture and improve the agency's patch management plan.

European Events

Call for Abstracts

• Submit a paper abstract by July 1 or a poster abstract by Oct. 31 on global manufacturing trends and outsourcing supporting tools for presentation at the Outsourcing/Contract Manufacturing Conference in Barcelona, Spain.

June 2016

• June 9: At the Virus Filtration training course, you will receive a thorough introduction to virus filtration. During the course, an interactive session will help you learn to design an efficient virus filtration process, and a practical session will provide hands-on experience with lab-scale modules. Register now.
• June 28-29: The 1st PDA Europe Annual Meeting will offer multiple tracks addressing big data processing, modern analytical techniques, data integrity, drug administration and more. Don’t miss this opportunity to stay current and become informed about future advances in modern sterile manufacturing and quality oversight! Register now.

U.S. Conferences and Session Recordings

June 2016

• June 20-21: Time is running out to register for the 2016 PDA Biosimilars Conference. Industry experts and regulators will present case studies focused on demonstrating analytical similarity, managing critical CMC steps in an accelerated development program and more.

October 2016

• Oct. 24-26: The 11th Annual PDA Global Conference on Pharmaceutical Microbiology will feature presentations from members of the pharmaceutical industry, research institutes, academia and government who will discuss current hot topics. Don’t miss this opportunity to learn about emerging infections such as the Zika Virus, combination product manufacturing, environmental monitoring, contamination control and more. Register before Aug. 11 and save up to $600.

November 2016

• Nov 3-4: At the 2016 PDA Outsourcing/CMO Conference, you’ll hear relevant case studies that demonstrate the importance of shared goals and partnership in bringing important therapies to ever-wider markets. In addition, industry leaders will share their experiences in driving collaborative best practices for development and commercial execution. Register before Aug. 23 and save up to $400.

Session Recordings

On-Demand Recordings: 2015 PDA Pharmaceutical Quality Metrics Conference Session Recordings

Education Courses

August 2016

• Aug 2-3: Learn to effectively apply statistics in a real-world setting by attending PDA Education’s Understanding Variation and the Metrics of Process Monitoring course. This two-day course presents basic concepts within a cGMP framework using analytical and manufacturing tools.
• Aug. 15-18: Three courses will be offered as part of PDA’s Quality Week. The courses will teach you how to design a more effective and efficient non-production process; identify, consider, collect and analyze the appropriate data to drive continuous improvement; and apply quality risk management to your operations. Register today!
• Aug. 30-Sept. 1: At PDA’s Environmental Monitoring Course Series, comprised of two courses, you’ll learn microbial and particulate control concepts and principles as they relate to the manufacture of pharmaceutical products. Register now.

Membership and Chapters

• The June PDA Letter is now available: Find out how a "line of sight" can help you design a risk evaluation method for aseptic processing. Also, take a look at photos from PDA's recent Packaging Conference and Annex 1 Workshop.

June 2016

• June 14: Hear two presentations from senior quality management professionals about facility-related challenges at PDA’s Midwest Chapter event. Lunch and a tour of bioMérieux will follow. Register now.
• June 16: The PDA West Coast Chapter event on biosimilars will highlight business, regulatory and technological aspects of biosimilars and will cover how developing highly similar biologic therapies requires better product understanding and new approaches to tailor product quality attributes on demand. Register now.