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  • Location

    Online

  • Duration

    1 Day

  • Level

    Certificate

  • Next Intake

    Aug 2021

Course overview

 

The aim of this 1-day course (August 20th) is to provide learners with the tools to write better technical documents, focusing on the skills required to produce accurate, precise, succinct documentation within a manufacturing setting. 

On completion of this training, the participant will be able to;

  • Identify regulatory expectations for technical writing
  • Demonstrate documents and reports are structured, compliant, and presented in a consistent
    manner.
  • Demonstrate ability to write with a focus
  • Present information in a clear and concise manner to a defined audience

Participants who complete this 1-day course will receive a Certificate of Completion. 

 

Innopharma Education Students

Course Outline

This is a one-day course running online on the 20th of August 2021. Develop in-demand skills in technical and report writing, audit documentation preparation, and regulatory requirements for documentation. 

Module 1: Good Documentation Practice

  • What is Good Documentation Practice
  • Principles of Documentation for Pharmaceutical and Med-tech – EU and FDA Guidelines
  • Documentation Rules
  • Standard Operating Procedures (SOPs) / Work Instructions (WI)
  • Good practice v’s bad practice (checks, rounding, abbreviations, etc)

 

Module 2: Data Integrity

  • Assurance of the accuracy and consistency of data over its entire life-cycle
    Impacts of breach of data integrity
  • Data Integrity and compliance with cGMP Guidance for industry, 21CFR Part 11, Electronic
    records and Electronic signatures
  • Case studies on falsification of data (case studies will vary on audience e.g. Calibration,
    Analytical, Operations). ALCOA plus principles used.

Module 3: Technical Writing 

  • Purpose and delivery of technical writing
  • Planning and presenting technical documentation for a variety of situations
  • Writing appropriately for a defined audience
  • Designing reports with a logical flow to communicate effectively

 

 

Information for Employers

This programme is funded under the Skills to Advance initiative.  Employers interested in registering their employees on this course are requested to fill in the online form.  Once this form is submitted a member of our team will call you to discuss the funding and programme in greater detail 


Career Options

This course is suitable for those working within the manufacturing industries who may be dealing with documentation. Participants will develop in-demand skills in technical and report writing, audit documentation preparation, and regulatory requirements for documentation. 

Apply Now

To apply, please fill in the enquiry form at the top right of this page. A member of our team will be in contact soon after.

Why up-skill for the pharmaceutical industry in Ireland?

  • €3 billion in new capital investment
  • €39 billion in exports
  • Over 55,000 employed
  • 9 of top 10 world’s biopharma companies in Ireland
  • 12 of the top-selling drugs made in Ireland
  • Over 8,000 new jobs predicted by 2020
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Testimonials

Testimonials

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The lectures all come from the industry so they know what the Pharmaceutical companies are looking for

Laura McCarthy, ERP Automation Admin at Pfizer Certificate in Pharmaceutical & Medical Device Operations Graduate