Live web seminar on Starting the Quality System From Scratch BY Compliance2go by compliance2go


									Live Webinar on : Starting the Quality System From Scratch Tuesday, June 05, 2012
duration : 01:00 to 02:30 PM EST


                                      For the beginner, the course provides a logical and
                                      graphical perspective, enabling them to understand how
Get 15 % Discount as a early bird     quality principles and quality subsystems relate to their
registrations. Use Promo Key :        role and responsibilities. They will better understand
 CGO15                                their current quality system.

Who will benefit                      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
- Senior Management                   them better manage quality, solve problems, improve
                                      internal auditing, and make quality system
- Warehousing                         improvements.

- Purchasing Managers and
Procurement Managers                  The opportunity to design a quality system from scratch
                                      offers great rewards in experiencing and understanding
- Laboratory Analyst                  the functions of quality systems. For me, this “dream”
                                      of building the “perfect quality system” began during
- Cost Accounting                     my early quality management days as I learned and
                                      experienced quality system successes and failures. I
- IT                                  learned from these thinking and dreaming, “If only I
                                      could set up my own quality system”.
- Documentation Management

- Upper Management functional
or departmental heads of Quality,     Finally, this dream came true when I was given the
Production and Operations,            opportunity to design and implement a combination
Research and Development, Sales       pharmaceutical and medical device quality system from
and Marketing, Human                  scratch. Since this first experience, I have designed and
Resources, and Finance                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
Live ( Single registration ) : $189.00            cautious of “foreign aid”
Group ( Max 10 Attendee): $249.00            3. Planning the Quality System-It’s not just for
On Demand (Recording available):$289              quality anymore.
Get Training CD : $499                       4. The Quality Manual & Technical Manual
                                                  captures, organizes, controls and preserves
                                             5. Facility Design and Maintenance
                                             6. Equipment Design, Qualification, Calibration,
                                             7. Supplier and Contractor Qualification
                                             8. Packaging and Labeling
                                             9. Coordinating activities with Regulatory Affairs
More Trainings                                    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

                                            .

                                         . 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

                                     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 Chemistry..

                       Compliance2go |
                       Phone : 877.782.4696 | Fax : 281-971-0286
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