Batch Production Record and Device History Record Review and Quality Assessment

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Batch Production Record and Device History Record
Review and Quality Assessment
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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 has written
  numerous submission documents for product,
  process and facility approval/licensing which
  also required the development of quality systems
  which included customer complaint management,
  deviation management, CAPA and associated site
  wide employee training. 

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• Description
• Written procedures are to
  be established and followed for a time efficient
  and clear evidence of the quality related
  elements during the review and approval for
  release, including packaging and labeling, to
  determine compliance of the intermediates (FDA
  definition) and/or finished product with
  established specifications before a batch can be
  released for distribution.
• Why Should you Attend
• A vast majority of the current
  industry deficiencies which have led to isolated
  483s, Warning Letters and Consent Decrees are the
  result of deficient technical documentation of
  the production processes for both injectables,
  devices and solid dosages. 

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• Objectives of the Presentation
• Generation of BPRs, DHRs and SOPs to provide
  technically written instruction sets to eliminate
  operator errors. Training is NOT the primary
  means of generating and error free operation.
• Production and In-Process Controls
• Inspection, Packaging and Identification Labeling
  of Finished Products and Intermediates
• Responsibilities for Production Activities
• Data selection and entry into the statistical
  tracking from the BPR and DHR
• Incident / Deviation Tracking along with Customer
  Complaints and CAPA changes
• Annual Reports.
• Who can Benefit
• Quality and Documentation
  Personnel within the industry.

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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate 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 formate will be
  mailed to you
• Get certification of attendance.

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