New Audio Seminar

Cost Effective – Time Effective – In your Conference Room or Office

Implementing FDA’s New Guidance:
Quality Systems Approach
to Pharmaceutical CGMP Regulations
New Recommendations to Facilitate
Modernization of Drug Manufacturing

Conducted by David Markovitz

On September 29, FDA issued a final guidance on a quality systems approach. 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 now is, “What must we do to comply with this new guidance?”

This audio seminar, conducted by David Markovitz, an expert on GMP training and implementation, will examine the new guidance 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 audio seminar with a PowerPoint presentation constructed specifically for this seminar and ask questions and interact with Mr. Markovitz during the audio 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.

Implementing FDA’s New 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.

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 teleseminars and webcasts sponsored by the Institute of Validation Technology and Advanstar Communications.
A Member of the Editorial Advisory Board of the Journal of GXP Compliance.
An internationally recognized and award-winning speaker and workshop leader.

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Missed this seminar? Purchase the CD

You can listen to this seminar on CD and receive a written transcript of the seminar, including questions and answers.

BP1019E
Implementing FDA’s New Guidance – Quality Systems Approach to Pharmaceutical CGMP Regulations
CD, HANDOUT MATERIALS, AND TRANSCRIPT (PDF)

$397.00