August 2016

Temecula Valley Section 0713

August 2016 Monthly Dinner Meeting

Topic: GMP

Who: David Markovitz

When: Thursday, August 18th,, 2016 at 6:00 PM

Where: Temecula Library Click Here for Map
30600 Pauba Road, Temecula, CA 92592

Dinner Cost:
$25.00 for non-members
$20.00 for member

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Presentation Title: “Making Quality and Good Manufacturing Practice (GMP) a Lifestyle in your Company, and NOT Just a Regulation or Corporate Policy

Good Manufacturing Practice (GMP) is a set of regulations enforced by the US Food and Drug Administration upon manufacturers of pharmaceuticals, medical devices, biologics, dietary supplements, cosmetics, and food products. The primary purpose of the regulations is to ensure the quality, efficacy, and safety of these products – thus ensuring the health and safety of the public.

When GMP is viewed as part of the fiber or culture of a company, and not merely as a regulatory hurdle to overcome, the results are not only higher quality, but lower costs, fewer mix-ups and errors, higher productivity, less stress in the workplace, happier customers, and higher profits.

David will share with you how to embed the principles of GMP and quality into the culture of your company. This session will cover the fundamental principles of GMP and quality as well as looking at GMP and quality from six critical perspectives (the product, the process, the project, the paperwork, the people, and the patient).

By attending this session, you will:

  • Gain a better understanding of the FDA’s regulatory requirements for manufacturing high quality products
  • Discover ideas on how to embed the principles of GMP and quality into your strategic approach to business
  • Learn to view GMP compliance and quality management from a systems viewpoint

Presentation Speaker: David C. Markovitz

David Markovitz, Founder and President of GMP Training Systems, Inc., has over three decades experience in FDA regulated industries. David honed his expertise on Quality Systems when he had the rare privilege of assisting Dr. W. Edwards Deming, the 20th century’s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming’s teachings and develop a Quality Systems approach.

After two decades in Operations Management with four leading companies, David started GMP Training Systems, Inc. in 1996 to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization.

Come join us for an educational presentation on GMP at the Temecula Library by David Markovitz on August 18, 2016 at 6:00pm!!!

This lively training presentation teaches how to use all six – yes, six! – senses when conducting external conformity assessments or internal QMS audits, in order to maximize the gathering of objective evidence, and to ensure the highest level of confidence in the final audit results.
This eye-opening and invaluable discussion will give even seasoned auditors a new perspective, and will help improve the audit experience not only for clients, but also dramatically reduce problems with Certification Body internal review committees and Accreditation Bodies.
As a clinic participant, you will:
The “angle of perception” used by auditors, and how to expand it using the “missing senses” to soak up evidence like a sponge.
Learn how auditees hide nonconformities in plain view, based on predicted auditor behavior.
Never again have your audit findings challenged because of weak evidence.
Speaker Bio: Christopher Paris is a former Chemical Process Engineer, and has worked with ISO 9001 systems since 1988.  In 1999, he founded Oxebridge Quality Resources, an ISO 9001 and AS9100 consulting firm whose clients include SpaceX, Lufthansa, L3 Communications, and
200 small and medium sized organizations. He was a member of the US TAG to TC 176,
and is an international speaker on the subject of quality and ISO 9001, primarily advocating
for the point of view of standards users.  Click Here for more on Christopher Paris bio.