2014 PDA/FDA Joint Regulatory Conference

Connecting Regulatory, Quality, Science & Compliance:
Assuring Customer-Focused Outcomes
throughout the Product Lifecycle
September 8-10, 2014
Renaissance Washington Hotel
Washington, D.C.
Conference: September 8 - 10 Exhibition: September 8-9 Post-Workshop: September 10-11 Courses: September 11-12


Conference Program Participants

Program Highlights

Hear the FDA’s views on Scientific Advances and their Impact on Manufacturing of the Future.

View on YouTube

Current Agenda

     Highlights from the three-day conference include:

  • FDA's views on Manufacturing of the Future
  • Regulatory and Industry Discussion on the Cost of Quality and Views on Quality of Culture
  • Concurrent sessions on 1) Product Quality 2) Innovation: Regulatory Challenges and Opportunities and 3) Lifecycle Management
  • Over Fifteen Interest Groups & Breakfast Sessions
  • The popular Compliance Update and Center Initiatives Sessions
  • Over 60 Regulatory and Industry Presenters



It is important that organizations continue to improve and adequately resource change management systems. Key considerations for organizations include management accountability for supporting needed changes, and linking change management to the quality risk management system to ensure that the change is carefully managed and change effectiveness is verified.  he critical underpinning of all of these quality system efforts is a strong quality culture.  

With this in mind, the FDA and PDA are again collaborating to plan the 2014 PDA/FDA Joint Regulatory Conference. The objectives for this collaboration are to promote the adoption of more robust design practices, quality systems, and use of modern manufacturing technology with the ultimate goal of improving medical products quality for the consumer.  Together, these two organizations, along with a number of other stakeholders, are working to move manufacturers toward a future state that has been described as:

“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight. (Janet Woodcock, 2005)”

Learning Objectives

At the completion of this program, participants will be able to:

  • Explain the industry measures and regulatory expectation on the drug shortage issue currently facing patients the industry
  • Examine approaches to managing supply chain concerns interruptions or crises related to their products
  • Show how to effectively handle post inspectional follow-ups including responding to 483's or regulatory expectations and meeting requests
  • Identify key performance indicators for measuring quality with in their company
  • Describe the importance of a robust quality agreement and supplier oversight
  • Define the issues and challenges of outsourcing activities
  • Summarize FDA's expectation for submissions
  • Summarize expectations on cGMPs for Active Pharmaceutical Ingredients (APIs)
  • Describe the current thinking and regulatory framework regarding Good Distribution Practices (GDP)
  • Apply the enhanced concepts of continual process validation stick to ICH terminology: 'process validation' or 'continued process verification' to their products and processes

Who Should Attend


  • Research & Development
  • Regulatory Affairs
  • Manufacturing
  • Quality
  • Assurance/Control
  • Marketing
  • Sales

Job Functions

  • Supply Chain
  • Clinical Supply Material Preparation
  • Executive Management

Related Events


Listen to Steven Mendivil, Amgen, Planning Committee Member, speak about the 2014 PDA/FDA Joint Regulatory Conference.


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Gold Valsource Azzur Group PDA FDA
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