2007 PDA/FDA Joint Regulatory Conference September 24-28, 2007

2007 PDA/FDA Joint Regulatory Conference September 24-28, 2007
Washington, DC
Are you looking for practical guidance on how to address evolving regulatory expectations using a scientific and risk-based approach in the global marketplace?
Get the information you need to meet these expectations at the 2007 PDA/FDA Joint Regulatory Conference!
The adoption of new global regulatory proposals like the ICH Global Quality System Guidances, FDA?s GMPs for the 21st Century and Critical Path initiative, has sparked the need for the pharmaceutical industry and regulatory authorities to determine the next steps for implementation and to continue the development of practical approaches to:
Apply these concepts in the new paradigm of Design Space, Quality by Design, and risk-based approaches to Quality Systems
Implement new strategies with minimal impact on manufacturing, quality and regulatory functions
Comply with new regulations without disrupting the normal flow of processes
Hear directly from FDA, EMEA, MHLW and PIC/S representatives regarding emerging risk-based approaches, including first cycle approval, harmonization and critical path initiatives, as well as from industry experts who will relay case studies about adopting these concepts without delaying or disrupting product approvals and supplemental filings.
Take home practical approaches to compliance that you can implement as best practices at your organization!

Who Should Attend

Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales
Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Contact

For more information about the conference please contact:
Wanda Neal-Ballard
Vice President, Program and Registration Services
Tel: +1 (301) 656-5900 ext. 111
Fax: +1 (301) 986-0296
Email: neal@pda.org
For more information about exhibition and sponsorship opportunities please contact:
Cindy Tabb
Manager, Sales
Tel: +1 (301) 656-5900 ext. 222
Fax: +1 (301) 986-0296
Email: tabb@pda.org