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U.S. Conferences and Session Recordings
June 2016
- June 20-21: At the 2016 PDA Biosimilars Conference, industry professionals and regulators will discuss new developmental strategies for biosimilars. Successful case studies will be presented to illustrate how to establish an appropriate quality target product profile. Register now!
| Take advantage of substantial savings with PDA’s FLEX PASS. Book three registrations from your organization to PDA’s Fall signature events by July 1 and save substantially! |
September 2016
- Sept. 12-14: When you attend the 2016 PDA/FDA Joint Regulatory Conference, you’ll gain an understanding of the regulatory expectations and requirements of current regulatory programs. Hear updates from FDA regulators and industry experts on current efforts that are impacting global regulatory strategies and gain practical solutions and advice for today’s regulatory challenges. Register before July 1 and save up to $600!
October 2016
Session Recordings
 On-Demand Recordings: 2015 PDA Pharmaceutical Quality Metrics Conference Session Recordings
On-Demand Recordings: 2015 PDA Visual Inspection Forum Session Recordings
Education Courses
August 2016
- Aug. 15-18: At PDA’s Quality Week, you will learn how to design more effective and efficient non-production processes and find out how to identify what quality metrics or performance indicators your operation needs to consider. Register now.
November 2016
Membership and Chapters
May 2016
- May 18: The PDA New England Chapter invites you to attend the Cleanroom Microbiology and Contamination Control Event. Jeanne Moldenhauer, Excellent Pharma Consulting, and Brian Hubka, Contamination Prevention Technologies, will present various methods for environmental monitoring and ways to control contamination in a facility. Register today!
- May 19: Register today for the PDA Texas Chapter Full-Day Conference hosted by Pfizer (Hospira). Network with industry colleagues and hear informative presentations on quality metrics, data integrity and aging facilities. The agenda also includes the option of participating in roundtable discussions or a manufacturing tour of Pfizer’s facility in Austin, TX.
- May 25: Envirotainer and United Airlines TempControl will present an overview of today's cold chain logistics concerns at the PDA Capital Area Chapter Controlled Temperature Shipment Event. Presentations will focus on using available data to effectively meet the “chain of custody” as stipulated by GDP. Register today.
June 2016
- June 1: At the PDA Metro Chapter Microbial Monitoring 2016 Event, six industry experts will share their insight on microbial monitoring practices for sterile, non-sterile and biotech operations. Presentations will describe USP microbial control activities for sterile and non-sterile operations and endotoxin control. Register today.
Scientific and Regulatory Affairs
- Richard Moscicki, MD, Deputy Director for Science Operations, CDER, FDA, reviews and compares each of CDER’s expedited pathways for drugs with a breakthrough therapy designation in a CDER Conversations article to help readers understand the terminology being used and the implications of expedited reviews and approvals.
- Comments are due June 24 on the U.S. FDA draft guidance, Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. This draft guidance provides recommendations regarding development and validation of immune assays for assessment of the immunogenicity of therapeutic protein products during clinical trials.
- CDER launched its new electronic CDER Export Certification and Tracking System. The system allows users to request a CDER Certificate of a Pharmaceutical Product (CPP) online as an alternative to a paper submission. The new software provides many features; including reducing the amount of time it takes to process a certificate, a step-by-step guide to applying for a CPP, real-time validation of data submitted and email notifications regarding the status of a CPP request.
European Events
May 2016
June 2016
- June 9: The Practical Application of GMP for Development of ATMPs course is most beneficial to those interested in or currently manufacturing ATMPs. This course will review and discuss available regulatory guidances on GMPs for ATMPs. Register today.
- June 28-29: Immediately following the 1st PDA Europe Annual Meeting, five courses will be offered that provide additional, in-depth training on root cause investigations, how to develop and process pre-sterilized primary packaging systems, the common materials used for the development and manufacturing of syringe systems, cleaning and disinfection and how to find the right GMP for APIs. Register today.
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