New Revisions to Drug cGMP: What You Must Do to Comply

Conducted by David Markovitz - President, GMP Training Systems, Inc.

Nov 14, 2008

This seminar will go over the revisions FDA has made to the pharmaceutical cGMPs. The major areas that have been revised are:

• Aseptic processing - addition of sterilization, validation, microbiological testing, and bioburden testing
• Elimination of asbestos filters
• Verification by a second individual requirements in charge-in of components, calculation of yields, equipment cleaning and maintenance, and batch production and control records

This seminar will also cover:

• FDA's reasons for making these changes
• Consequences of not being prepared
• What you need to do to get ready

Conducting this web seminar is David Markovitz, President of GMP Training Systems, Inc. David's career includes over two decades of Operations Management experience in FDA regulated industries. David knows what it takes to get fully prepared.

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Mr. Markovitz. An outline of this seminar and Mr. Markovitz' qualifications can be found below.

BONUS HANDOUT

Copy of FDA's Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals

New Revisions to Drug cGMP

Register now!

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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.

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Audio recording and handouts. You can download an MP3 file or we mail you a CD. GMP081114C New Revisions to Drug cGMP

$397.00

Instructor

David Markovitz

David Markovitz is the President of GMP Training Systems, Inc., an education, training, and consulting firm whose mission is 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. With a corporate background of management positions in Manufacturing Operations for four different companies over two decades, David knows first hand how to overcome the challenges in implementing quality systems.

David honed his expertise on Quality Systems when he had the rare privilege of assisting Dr. W. Edwards Deming, the 20^th 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.

A leading thought leader in the FDA regulated industry, Mr. Markovitz is:

• The author and/or co-author of several books and booklets focused on quality optimization.
• The creator of the GMP Training System™ - for both instructor led and computer based trainings
• A contributing author to the Journal of GXP Compliance.
• The creator, host and moderator of FDA web seminars and webcasts. 
• A Member of the Editorial Advisory Board of the Journal of GXP Compliance.
• An internationally recognized and award-winning speaker and workshop leader.

Please forward this to your colleagues who may be interested.