PDA Connector
 
 
WEDNESDAY, 19 JUNE 2024
 
 
 
 
 
This Week at PDA
 
 
Build your reputation and share your expertise by publishing your individual or collaborative work in the PDA Letter.

We are continuously seeking articles written by active PDA members on a wide variety of topics, including aseptic processing, biotechnology, regulations, manufacturing science, and supply chain.
 
 
 
 
Upcoming Events
 
 
PDA Cell and Gene Pharmaceutical Products Conference
 
10-11 JULY │
Tokyo, Japan
 
Explore Recent Breakthroughs.
Delve into advanced sessions exploring best practices, standards, and the latest developments in cell and gene therapy manufacturing.
 
PDA/FDA Joint Regulatory Conference
 
09-11 SEPTEMBER │
Washington, DC
 
Save Up to 20% During Early Registration.
This conference continues to be the essential annual CGMP event to attend to receive live and highly relevant CDER, CBER, CVM, and ORA updates.
 
PDA Pharmaceutical Microbiology Conference
 
07-09 OCTOBER │
Washington, DC
 
Present Your Poster!
Showcase your cutting-edge research and innovations at this popular conference! Poster submissions are due on 30 June.
 
 
 
 
 
 
PDA GMP COMPARISON WORKSHOP 2024
11-12 SEPTEMBER | WASHINGTON, DC
 
Ensure CGMP Compliance.
Get ready for group discussions, case studies,
role-playing exercises, and presentations on
CGMP specific to aseptic processing
in four best practice areas.
 
 
 
 
 
 
News and Noteworthy
 
 
Unleashing the Power of AI
 
Unleashing the Power of AI

 
Delve into AI implementation in pharmaceutical manufacturing, drug development process optimization, predictive analytics and resource optimization, and human-AI collaboration.
 
Capital Area
 
Free Chapter Event at the PDA Headquarters
 
Join the Capital Area Chapter at their 25 June event! Hear from US Pharmacopeia (USP), explore advances in AI for drug development, and network with other professionals in the area.
 
 
 
 
 
 
SPONSORED ARTICLE
 
 
PMS
EM Handbook Download
 
This guide to pharmaceutical environmental monitoring covers everything from the science behind the regulations to the techniques needed meet them. 
 
 
 
 
 
 
ANSI/PDA Standard 02-2021
Do You Have Your Copy?
 
Get guidance on establishing suitable procedures for the cryopreservation and recovery of biological cells in cell and gene therapy products and regenerative medicine manufacturing.

This standard has been included in a listing of recognized standards for regenerative medicine therapies by the U.S. FDA Center for Biologics Evaluation and Research.
 
 
 
 
 
 
PreFilled Call for Posters
 
 
 
 
 
Workshops and Webinars
 
 
PDA Alternative Microbiological Methods Workshop
 
09-10 OCTOBER │
Washington, DC
 
Successful Evaluation and Adoption. Hear in-depth presentations covering everything from method selection to validation and be inspired by case studies. This workshop sells out quickly!
 
PDA Combination Products Workshop
 
24-25 OCTOBER │
Phoenix, AZ
 
Master the Essentials.
Get equipped skills in risk management, verification and validation, preparation for submission readiness, technology transfer, change management, and more!
 
PDA Annex 1 Workshop
 
05-06 NOVEMBER │
Dublin, Ireland
 
Practical Solutions. Join industry leaders as they offer valuable insights into a standardized approach to navigating the requirements of the revised EU GMP
Annex 1.
 
 
 
 
 
 
Advance Your Education
 
 
Fundamentals of Aseptic Processing
Fundamentals of Aseptic Processing
 
30-31 July | Berlin, Germany
Through data-driven presentations and virtual reality, gain insights into guidelines, Warning Letters, and practical solutions for everyday challenges.
 
 
 
The Impact of CGMPs on Biomanufacturing Facility Design and Operation
The Impact of CGMPs on Biomanufacturing Facility Design and Operation
 
12 September | Washington, DC
Through case studies and interactive exercises, learn how to interpret and apply Good Manufacturing Practices on biomanufacturing facility design and operation.
 
 
 
Biotechnology: Overview of Principles, Tools, Processes and Products
Biotechnology: Overview of Principles, Tools, Processes and Products
 
12-13 September | Washington, DC
Stay ahead of this rapidly evolving field! Biopharmaceutical product development, biomanufacturing strategies, and types of products and their applications in medicine are covered.
 
 
 
 
 
 
 
 
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