Hear a message from Vince Anicetti, Keck Graduate Institute of Applied Life Sciences, co-chair of the 2012 PDA Annual Meeting talk about this year's exciting program.

Overview

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The 2012 PDA Annual Meeting is the one meeting each year dedicated to advancing the careers of pharmaceutical and biopharmaceutical professionals by focusing program content on science and technology innovation as well as optimized performance, offering extensive formal and informal networking opportunities and providing a forum to contribute to and influence the advancement of science and regulation in the industry.

The 2012 PDA Annual Meeting's theme is Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology. The manufacturing of quality products is a keystone of our industry. With the emergence of new technologies, our program will feature a one day track on personalized medicine focusing on challenges in manufacturing and quality assurance/quality control of these products. The program will also feature sterile biopharmaceutical manufacturing with a focus on manufacturing innovations and new technologies, as well as regulatory perspectives on biopharmaceuticals. Properly planned and performed process design, development, validation, sourcing, process control, contamination control, testing, handling, product and supply chain security, distribution, and manufacturing all drive product quality and essentially positive business results. Use of innovation and new technologies helps to ensure success of these processes. This conference will bring together experts from academia, industry and regulatory agencies from around the world to discuss current practices and opportunities in sterile and emerging biopharmaceutical manufacturing.

This meeting is an opportunity to participate in presentations, case studies and initiate discussions on manufacturing innovation, productivity in large scale sterile manufacturing and contract manufacturing, automation, and new technologies such as personalized medicine and cellular therapeutics. In additional, the meeting will offer a track for biopharmaceutical foundations to focus on the basics and fundamentals of industry practices. This track is intended for those who are new to the industry or who have a new focus in their career and will cover topics such as contamination control, quality control testing, process control, validation and supply chain.

Immediately following the Conference on Thursday and Friday, PDA’s Training and Research Institute (PDA TRI) will be offering several courses designed to complement what you’ve learned at the Conference. These courses will focus on Biotechnology and Bioprocessing, Sterile Dosage Forms and Operation and Design of Cleanrooms.

Learning Objectives

The program will cover:

• The latest technical advances in personalized medicine, cellular therapies and sterile biopharmaceutical manufacturing
• Challenges in manufacturing and quality assurance/quality control of sterile products
• Keynote lectures on the future of personalized medicine and biopharmaceuticals
• Current regulatory expectations, philosophies and challenges for manufacturing processes and emerging technologies
• Microbiological control in the manufacturing environment for biopharmaceuticals and advanced aseptic technologies
• Case studies highlighting techniques to plan and implement biopharmaceutical process development, manufacturing, testing and distribution procedures using risk- and science-based approaches, LEAN manufacturing approaches, statistical process control, PAT, etc.
• Newly released PDA Technical Reports and use of PDA training programs to improve process development, manufacturing, testing and distribution of sterile products

Who Should Attend

Any and all who are involved in the development, manufacture, testing and distribution of regulated biopharmaceutical, drug and healthcare products – including:

Departments:

Manufacturing | Quality | Research & Development | Process Development | Regulatory Affairs | Engineering | Laboratory Science | Information Technology | Validation | Training

Job Functions:

Executive Management | Mid-level Management | Project Management | Technical Services | Supply Chain | Manufacturing Application | Risk Management | And for those new to their job function, we strongly recommend the Foundations Track

Specialties:

Biopharmaceuticals | Personalized Medicine and Advanced Cellular Therapies | Biologicals | Medical Devices | Active Pharmaceutical Ingredients | Combination Products | Nutriceuticals