Cost Effective and Convenient - in your office or conference room

Implementing FDA's Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations

New Recommendations to Facilitate Modernization of Drug Manufacturing

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

July 30, 2009

The FDA guidance on a quality systems approach has been in place for only a short time. This document prescribes a set of formalized practices and procedures to ensure the quality of human and veterinary drugs and human biological drug products during manufacturing.

The question before us is, “What must we do to comply with this guidance?”

This web seminar, conducted by David Markovitz, an expert on GMP training and implementation, will examine this guidance document in detail and identify the practices that need to be in place to achieve compliance.

The guidance document will be examined with regard to FDA’s quality systems model.

• Management responsibilities
• Resources
• Manufacturing operations
• Evaluation activities

Lasting just one hour, you will be able to follow along on this web seminar with a PowerPoint presentation constructed specifically for this seminar and ask questions and interact with Mr. Markovitz during the seminar.  A detailed outline and Mr. Markovitz’ qualifications follow below.

By the end of the hour, you should have a better understanding of how to implement this new guidance into your operation.

BONUS HANDOUT - FDA Guidance on Quality Systems Approach to Pharmaceutical cGMP Regulations

Implementing FDA’s Guidance – Quality Systems Approach to Pharmaceutical CGMP Regulations

Part I  CGMPs and Quality Systems

• Quality by Design and Product Development
• Quality Risk Management'
• CAPA - Corrective and Preventive Action
• Change Control
• The Quality Unit
• FDA's Inspection Model - The Six Systems

Part II  The Quality Systems Model - Management Responsibilities

• Provide leadership
• Organizational structure
• Building your Quality System to meet requirements
• Establishing policies, objectives, and plans
• Reviewing your system

Part III  The Quality Systems Model - Resources

• General arrangements
• Personnel development
• Facilities and equipment
• Controlling outsourced operations

Part IV  The Quality Systems Model - Manufacturing

• Design, development, and documentation of products and processes
• Examining inputs
• Performing and monitoring operations
• Addressing nonconformities

Part V  The Quality Systems Model - Evaluation activities

• Analyzing data for patterns
• Conducting internal audits
• Quality risk management
• Corrective and preventive actions
• Promoting improvement

Part VI  Discussion and Questions and Answers

• David Markovitz will field your questions live on the phone. You will hear all questions and answers from all participants of this audio seminar.

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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Get the MP3 file and handout GMP090730E - MP3 audio file and Handout materials Implementing a Quality Systems Approach

$397.00

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 instructor-led, computer-based, and web-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.