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Enjoying a walk in Laguana Beach!

FDA QSR/GMP & Inspections

Date: Monday, July 21, 2008

Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

Overview: (see Special Offer below)
 
FDA enforcement actions; such as, Warning Letters & Consent Decrees for Quality System violations can have a devastatingly negative impact both financially, competitively, and emotionally on a company. This course will provide an understanding of FDA’s Quality System Regulation (QSR), 21 CFR 820, for medical device manufacturers and how it impacts all departments and personnel throughout an organization. The burden of complying with the QSR does not all fall on the Regulatory or Quality department. It is important that all departments throughout a company understand that they must fulfill their Quality System obligation in order for a Quality System to be compliant with the law. Understanding how you and your department’s role fits into the QSR puzzle is essential in complying with the Quality System regulation and not being the cause of an FDA enforcement action. This course will also explain how FDA conducts inspections, how to properly prepare, what can happen, and what to do if the inspection does not go well. This course will be beneficial to all employees of medical device manufacturers and their vendors.

What you will learn:

• The Elements of FDA QSR (21 CFR 820)
  
• Brief History and Rationale for QSR
  
• Key factors in obtaining and maintaining compliance
  
• Knowing when you are out of compliance and typical QSIT findings.
  
• What Quality System information is needed to support Submissions, PMA, 510(k), IDE
• Executive Management’s critical role in QSR compliance & QSIT inspections
  
• Concepts and considerations when implementing multiple quality systems such as FDA QSR, ISO 13485:2003, and ISO 9001
• How and what will FDA inspect
  
• Examples of non-conformances found by FDA
  
• FDA’s current hot buttons for or during QSR inspections
  
• How to know and what to do if you your inspection starts to experience problems!
  

Benefits of Attending:

• Lower risk of FDA enforcement actions
  
• Assist with the creation or maintenance of a compliant Quality System
  
• Help to create a more efficient Quality System
  
• Company preparation for next FDA inspection
  
• Cross-department understanding of QSR roles
  
• Lower personnel liability
  
• Higher quality products
  
• More buy-in and less departmental bickering
  
• Meet the training requirements of FDA
  
• You will be able to sleep at night!
  

Abbreviated Outline:

• A. Brief History and Rationale for the QSR (21 CFR 820)
  
• B. Why is QSR compliance important? What can happen!
  
• C. Definitions, confusing terms, mapping of terms & documents
  
• D. QSR Elements and common Departmental Roles in each
  
• E. Types of companies and their required QSR compliance
  
• F. Implementing multiple quality systems within one company, e.g. FDA QSR, ISO 13485:2003, ISO 9001
• F. Importance of Internal Audits and how to conduct
  
• G. Types of FDA Inspections, including Accredited 3rd Party Inspections
  
• H. FDA Inspection Methods, including QSIT
  
• I. How to Prepare for the Inspection
  
• J. How to handle the Inspection
  
• K. Typical Findings and current FDA Hot buttons
  
• L. Good & Bad Inspections-What happens next
  
• M. How to respond to an FDA enforcement action
  
• N. Summary & Review
  

Speakers: Rich Basler, Ray Pizinger, Jim Kozick

Special Offer: All in attendance will receive a free copy of the CD Rom containing the FDA's QSIT training module used to train FDA investigators on QSIT and its implementation.

Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!

Summer is very popular time to visit the Southern California Area.

Be sure to reserve your space and room early!