Masy Systems, Inc.

2010 PDA Annual Meeting Overview

The 2010 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, 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 2010 PDA Annual Meeting’s theme is Manufacturing Excellence. Manufacturing of quality products is a keystone to the value of our industry. For years, production efficiency and productivity has not been emphasized to the same level as most industries. Today, it is recognized that properly planned and performed process design, development, validation, sourcing, process control, contamination control, testing, handling, product and supply chain security, distribution, as well as manufacturing have a direct impact on manufacturing excellence and the cost of production. The control of excess, defects, contamination, counterfeiting and management of resources have a direct impact on the quality and cost of goods, enabling a greater value to our patients.

This meeting is an opportunity to participate in presentations, case studies and initiate discussions on manufacturing excellence, lean manufacturing, green design and operation, automation, new technologies and better process control. Sessions will focus on core competencies of manufacturing methods and techniques, as well as tracks that provide knowledge on innovative technology.

Learning Objectives

At the conclusion of this conference, you will:

• Discuss methods to safely and effectively manufacture quality drug products, while establishing, maintaining, and optimizing productivity.
• Describe approaches to challenge status quo in order to develop and accept better means of process optimization.
• Recognize the core competencies of good science, as well as incorporating innovative new approaches to assure productivity in combination with and largely as a result of quality product manufacture.
• Explain current regulatory expectations and be better able to design strategies to meet those expectations related to validation, operation, and control of manufacturing processes and technologies
• Illustrate advances in Manufacturing, Quality and Process Development technologies and their potential effect on and benefit to current practices
• Identify techniques to plan and implement drug process development, manufacturing, testing and distribution procedures using risk- and science-based approaches, LEAN manufacturing approaches, statistical process control, PAT, etc.
• Improve drug process development, manufacturing, testing and distribution using PDA Technical Reports and training programs

Who Should Attend:

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

Departments:

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

Job Functions:

• Supply Chain
• Executive Management
• Mid-level Management
• Project Management
• Technical Services
• Manufacturing Application
• Risk Management

Specialties:

• Pharmaceutical
• Biologicals
• Medical Devices
• Active Pharmaceutical Ingredients
• Combination Products