The New Paradigm: Quality and Compliance in Merging and Emerging Cultures
September 13-16, 2010 | Renaissance Hotel | Washington, D.C. | Add to Calendar
Margaret Hamburg, MD, Commissioner of Food and Drug Administration is confirmed as the opening keynote speaker for the 2010 PDA/FDA Joint Regulatory Conference.
Overview
The
PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join
FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes. Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance. You won’t find this level of direct information exchange with FDA at any other conference!
Take part in three dynamic learning tracks:
- Foundations: Get back to quality basics in times of change! Sessions will discuss CAPA, inspection management, recalls and quality unit responsibilities.
- Quality Today: Talk about the challenges facing today’s quality professional – including supply chain management, knowledge management and biologics.
- Merging and Emerging Issues: Focus on global regulations, merging quality systems, regulatory communication and foreign inspection practices.
PDA is also offering an exhibition during the conference. Further enrich your educational experience by attending the post conference workshop, 2010 PDA Extractables/Leachables Workshop (September 15-16) and PDA Training and Research Institute courses (September 16).
Learning Objectives
Attendees will leave this conference understanding and being able to:
- Administer practical approaches to compliance that industry can implement as best practices in their companies
- Discuss emerging risk-based approaches, including first cycle approval, harmonization and critical path initiatives and illustrate case studies in adopting these concepts without delaying or disrupting product approvals while increasing supplemental filings
- Integrate quality into the global business platform
- Leverage results to drive continuous improvement
- Interpret supply chain and good distribution practices for incoming materials as well as the final product for commercialization
- Define quality systems today as they relate to contract manufacturing.
- Manage product knowledge through product transfer activities
- Anticipate emerging regulations
- Summarize foreign inspections practices and expectations from foreign regulators
- Describe basic principles of New ICH Paradigm
- Identify the basic principles of the FDA Quality Systems including:
o CAPA
o Managing Regulatory Inspections
o Root Causes for Product Recalls
o Responsibilities of the Quality Unit
Who Should Attend
Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales
Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management
Contacts
Conference inquiries:
Wanda Neal, Vice President, Programs and Registration Services
Tel: +1 (301) 656-5900 ext. 111
E-mail: neal@pda.org
Registration inquiries:
Patresa Day, Assistant Manager of Registration and Customer Service
Tel: +1 (301) 656-5900 ext. 115
E-mail: day@pda.org
PDA TRI course inquiries:
Stephanie Ko, Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
E-mail: ko@pda.org
Exhibition/Sponsorship inquiries:
David Hall, Vice President, Sales
Tel: +1 (301) 760-7373; Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
E-mail: hall@pda.org
For more information about obtaining a U.S. visa, visit www.unitedstatesvisas.gov.