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 and Founder of GMP Training Systems, Inc.
August 16, 2013
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 new guidance?”
Learn what you can do to be proactive and prepared when FDA inspectors challenge you.
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
- Manufacturing operations
- Evaluation activities
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.
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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 presentation handout materials the day before the seminar.
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GMP130816E - audio recording and handout materials
Implementing FDA's Guidance on a Quality Systems Approach
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 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.
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.
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