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Certificate

Pharmaceutical Technical Writing

Program code:

Credential:

Certificate

Duration:

Delivery Mode:

Start Date(s):

January | May | September
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Program Overview – Pharmaceutical and Biopharmaceutical Technical Writing

An appropriate level of pharmaceutical and biopharmaceutical technical writing skills is essential across all areas of quality processes and systems. Individuals with strong expertise in technical writing have a significant competitive edge in the industry. This training program offers a structured, step-by-step approach to mastering technical writing for the pharmaceutical field, complete with real-world case studies.

After successful completion of this course, students will be:

  • Able to develop procedures, policies, protocols and reports
  • Able to investigate deviations and out of specifications
  • Able to analyze CAPA and change control review, tracking, and implementation
  • Able to review and approve documents
  • Able to prepare for inspection
  • Able to respond to inspection comments
  • Able to perform an effective gap analysis
  • Able to train employees

  • Technical writing overview
  • Technical documents and records
  • Technical procedures

  • Who can create technical procedures
  • How to write technical procedures
  • Case study: Writing a technical procedure

  • CAPA – Technical procedure
  • Change control systems – Technical Procedure
  • Case study – Creating change control

  • Gap analysis/Process Map
  • Data handling and trending
  • Case Study – Creating a process map

  • Protocol
  • Report
  • Other technical documents creation

  • Template creation
  • Case study: Protocol writing

Who Should Attend

Anyone who wants to become the following should attend the webinar on pharmaceutical technical writing:

  • Beginner level of technical writers or individuals wanting to become technical writers
  • Technical team members
  • Management team members
  • Auditors
  • Consultants
  • Change Control Coordinators
  • Managers
  • Technical Writers
  • Auditors
  • Regulatory Affairs Associates
  • Validation Specialists