CGMP Application for Design & Operation

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• CGMP Application for Design Operation

Design Operation
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• Instructor Profile
• Mr. Jerry Dalfors has extensive
  (40 years) of business administration,
  consultative, technical and managerial experience
  in the development and manufacture of highly
  regulated biopharmaceutical products including
  injectables, biologics, medical devices and oral
  dosages. He has held permanent employee,
  temporary employee and company representative
  management positions with a multitude of the
  major pharmaceutical and biotechnology companies
  in the US.  He has worked with or
  assisted more than two dozen companies with the
  establishment of controlled document/quality
  systems, FDA briefing and submittal documents,
  project management of several multimillion dollar
  projects including design, start-up and
  validation to assure fast track FDA approval by
  maintaining strict regulatory compliance during
  all phases of engineering, construction,
  commissioning and validation and more.

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3

• Description
• This presentation is intended to
  help manufacturers implement cGMP quality systems
  and risk management approaches during commercial
  development and operations after the initial
  preclinical studies, to meet the requirements of
  the FDA's current good manufacturing practice
  (CGMP) regulations (2l CFR parts 210 and 211).
• The FDA requires comprehensive
  quality systems highlighting the company's
  consistency with the CGMP regulatory requirements
  for manufacturing human and veterinary drugs as
  well as medical devices, including biological
  drug products. This program also explains how
  manufacturers implementing good manufacturing
  practices managed by quality systems can be in
  the best compliance with parts 210 and 211.

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• Why Should you Attend
• All individuals within a company
  manufacturing materials that are regulated by the
  country's government to ensure the design and
  established operations are going to be done in a
  way that will meet not only just the local
  regulations but wherever the product might be
  shipped as well as doing all you can minimize
  patient risk and increase the probability of
  profitability instead of paying outside
  contractors to fix your errors. 

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• Objectives of the Presentation
• The objectives of the presentation
  are to cover areas including
• CGMPs and the concepts of current quality
  systems, including quality by design and
  development, risk management, CAPA, Change
  Control, Management Responsibilities, Resources,
  Manufacturing and Evaluation Activities.
• Terms and Definitions - with related acronyms
• Quality Management System - Quality
  Profitability and does all it can to minimize
  operator errors, Management Responsibility and
  GMP/Quality Commitment
• Quality Policy - General elements of the Quality
  Manual and Individual Training Requirements for
  each job description.
• Human Resources - Individual employee files
  providing documented evidence of required
  education or experience and related training for
  the individual's position
• Purchasing, Incoming Control and Raw Material
  Release
• Gowning, Environmental Control and Monitoring
• Product Testing, Inspection and Document Review
  for Final Product Release
• Incident Tracking, Change Control, CAPA and
  Annual Quality Review

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• Who can Benefit
• FDA, ISO, PDA, ISPE, ASQ related employees
• Complaint - any written, electronic or oral
  communication that alleges deficiencies related
  to the identity, quality, durability,
  reliability, safety, effectiveness or performance
  of a product after it is released for commercial
  use.
• Lot or Batch - one or more components or finished
  product that consist of a single type, product
  code, class, size, composition, or software
  version that are manufactured under essentially
  the same conditions that are intended to have
  uniform characteristics and quality within
  specified limits
• Manufacturing Material - any material or
  substance used in or used to facilitate the
  manufacturing process, an intermediate or
  byproduct produced during the manufacturing
  process, which is present in or on the finished
  product.

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7

• Live Session - How it works?
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf format will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.
• Recorded Session - How it works?
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be
  mailed to you
• Get certification of attendance.

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8

• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
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