GMP Annual Training 2011

The GMP Annual Training 2011 is a webinar dedicated to Good Manufacturing Practices (GMP) Updates And FDA/Health Canada Regulations including:

• how GMP Compliance can enhance the Efficiency of your Organization
• Where the FDA is headed under its Commissioner
• How the revised 210/211 is allowing for Automated Equipment
• Is your Organization is meeting all Six Quality System Requirements
• What Happened to "Retrospective Validations" and What Happens Now
• The "New" Process Validation -- An Overview of What It Includes
• how others are meeting cGMP needs during the "live" Question and Answer Session
• How to use a Warning Letter to Improve the Quality within your Facilities
• The Issues Surrounding Out of Specification Results and Why This Guidance for Industry Document continues to cause Industry Problems
• Codification of Combination Rules -- Why Everyone is Affected
• How ICH Q9, Quality Risk Management, Can Benefit your Organization
• The Revisions to USP[61]/[62] Microbiological Examination of Nonsterile Products, and the Pitfalls Awaiting the Laboratory

Who should Attend

Delegates from Manufacturing, Facilities, Product Development, Research and Development, Quality Assurance, Project Management, Regulatory Affairs, Quality Control and Regulatory Compliance.