Webinar on The Hybrid Pharmaceutical GMP Quality System - From API To Final Dosage

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The Hybrid Pharmaceutical GMP Quality System -
From API To Final Dosage
Product Id
FDB1064
Category
Food, Drugs Biologics
Scheduled On
Tuesday, July 1, 2014 at 1300 Hrs
Duration
60 Minutes
Speaker
Howard T Cooper
To register for this webinar please visit
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• Webinar Description

Does your company need two GMP quality systems -
one for API and one for finished products? Your
answer is most likely thats the way the FDA or
my regulatory body has established the GMPs.
And that is certainly true. But have you closely
analyzed, for example, the objectives of these
systems, their content, similarities and
differences, and terminology? If you review the
history of GMP, you may wonder, Can I really
have a hybrid GMP system combining knowing their
similarities but also their differences? Next
perhaps one may question, Can there be one GMP
system? We believe this is possible by taking
the best from each of the GMP regulations and,
perhaps taking the device regulations, with a
single system. Attending this session will
provide a fresh perspective on GMP so that you
can see possibilities for improving or
remediating your current quality systems
by Understanding that compliance makes only a
limited use of quality principles and that there
are additional quality principles available that
will improve product and process with the added
benefit of achieving greater customer
satisfaction Providing a fresh perspective of
GMP and demonstrate that the principles of
quality are essentially the same in all
processes Understanding that technology/technical
processes have inputs and outputs and it is the
understanding of these inputs and outputs and
their control and analysis that make a difference
between success and failure Management support
and participation in the quality system
activities will help the company meet its
objectives

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Area Covered In The Session

• Part I - A Primer on How Good Manufacturing
  Practices Function
• Quick Objectives, Overview, Definitions,
  Similarity Differences
• A quick review of the product lifecycle and the
  supporting repetitive cyclic processes
• Understanding the functions of production,
  quality control, quality assurance, oversight,
  monitoring,
• and supporting functions
• Comparing ICH Q7A Part 210-211
• The role of FDA ICH guidance documents
• The Quality Manual and Learning from Part 820,
  The Quality System Regulation
• Factors that influence the decision to merge
• Part II - Planning the Merger (Citations from the
  GMP regulations accompanied by explanation in
• words and diagrams for each section)
• The Role of Senior Management, Organization and
  Personnel
• Documentation, Records and Reports or Quality
  Manual
• Knowledge Management, Design, Risk
• Facilities, Process Equipment Materials
• Production Process Control, Laboratory
  Controls, Packaging Labeling and Storage and
  Distributio

• Who Will Benefit

• Regulatory Affairs
• Product Management
• Supervisors Group Leaders
• Production Management
• Companies new to the FDA regulated industry
• Purchasing
• Compliance Management
• Quality Unit Vice Presidents Directors
• Vice presidents, Directors and Managers of
  Operations
• Consultants

• Speaker Profile

Howard T Cooper, President, EQACT, Inc.,
Independent Consultant, has over 40 years of
experience facing the challenges of managing,
designing, developing, implementing, and
mitigating GMP quality systems in the
pharmaceutical, medical device, food
industries.
To know more visit https//compliancetrainings.com
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