Live Webinar on : Starting the Quality System From Scratch Tuesday, June 05, 2012

duration : 01:00 to 02:30 PM EST

Description

Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

For the beginner, the course provides a logical and graphical perspective, enabling them to understand how quality principles and quality subsystems relate to their role and responsibilities. They will better understand their current quality system.

Who will benefit

- Senior Management - Warehousing - Purchasing Managers and Procurement Managers - Laboratory Analyst - Cost Accounting - IT - Documentation Management - Upper Management functional or departmental heads of Quality, Production and Operations, Research and Development, Sales and Marketing, Human Resources, and Finance

For the intermediate & advanced, they will be able to apply what they have learned to contribute significantly to building or revising new quality systems. It will help them better manage quality, solve problems, improve internal auditing, and make quality system improvements.

The opportunity to design a quality system from scratch offers great rewards in experiencing and understanding the functions of quality systems. For me, this dream of building the perfect quality system began during my early quality management days as I learned and experienced quality system successes and failures. I learned from these thinking and dreaming, If only I could set up my own quality system.

Finally, this dream came true when I was given the opportunity to design and implement a combination pharmaceutical and medical device quality system from scratch. Since this first experience, I have designed and implemented several quality systems (including virtual) that have resulted in successful preapproval inspections. I have also revamped failing quality

systems to make them more compliant and effective. - Any member of a team involved in starting up, revamping, or remediating a quality system

As you can imagine, starting from scratch and revamping failing systems is hard work, but the experience and knowledge gained is extremely valuable. The relationships built, both positive and negative, will last forever. I want to share these experiences with you so that you may gain insight about the hard work, expectations, pitfalls, and the rewards of starting a system from scratch.

Pricing

Areas Covered in the Session:

1. Which comes first the alligator or the egg? 2. Staffing & Training is key to success but be cautious of foreign aid 3. Planning the Quality System-Its not just for quality anymore. 4. The Quality Manual & Technical Manual captures, organizes, controls and preserves 5. Facility Design and Maintenance 6. Equipment Design, Qualification, Calibration, Maintenance 7. Supplier and Contractor Qualification 8. Packaging and Labeling 9. Coordinating activities with Regulatory Affairs in the approval process. 10. Headquarters is coming for a visit. 11. Do not forget the laboratory. 12. Commissioning & Qualifying the Facility 13. Trial runs ,Scaling up, and Process Validation 14. The Pre-approval l Inspection but first get know the local FDA 15. In-Process Controls & In-Process Testing 16. The Laboratory

Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

Get Training CD : $499

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. Learning Objectives
Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to

simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations. Key Topics to be Discussed: In 2010 under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, Site and IRB Inspections. Of those Inspections 9% or ~ 66 of the Clinical Investigator Inspections, 6% or ~ 15 of the IRB Inspections and 12% or ~ 15 of the Sponsor/Monitor Inspections were categorized as "Official Action Indicated". 45% of Clinical Investigator, 50% of IRB and 38% of Sponsor/Monitor Inspections were categorized as "Voluntary Action Indicated" being required. Because FDA Inspections are part of doing business and getting products to market, Clinical Investigators, Sponsors and IRBs should not only be prepared to handle an FDA Inspection but also be prepared to follow-up on findings, following the inspection.

About Speaker
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry..

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