Foundations of Investigation in Pharma and Medical Device Industries
Online Course Course

Foundations of Investigation in Pharma and Medical Device Industries

  • Dates 17 June 2024
  • Location Zoom
  • Hours 5 hours
  • Language English
  • Hours 15:00-20:00 Brussels
  • 14:00-19:00 UK
  • 09:00am-02:00pm New York
$780 Until 03 Jun 2024
$900 Until 17 Jun 2024
About the Course
Josh Magnus
Lecturer: Josh Magnus
Magnus Solutions was founded by Josh Magnus, Sterile manufacturing and cleanroom expert, Aseptic trainer and lecturer.
Previous positions:

>>The Aseptic Expert – Teva pharmaceuticals – Sterile plant in Israel
Monitoring, analyzing and improving environmental monitoring results, EM SME for audits and inspections (FDA, EU, IMH), managing the EM monitoring team (samplers), advise and consult the sterile plant manager, investigate EM OOS, staff training on sterile issues (gowning, cleanroom behavior, etc.), improving process, equipment and disinfectants for the cleanroom.

>>Training and development manager - Teva pharmaceuticals – Sterile plant in Israel
Planning and executing training plans for all staff and management.

>>Manager Cleanroom services dept. – HY Labs Israel
EM monitoring, physi

This course offers a deep dive into the methodologies and best practices for conducting investigations in the pharmaceutical and medical device industries. It covers the reasoning behind investigations, various investigative methodologies, tools used in the process, and the regulatory requirements for documentation and reporting. The course aims to equip attendees with the skills necessary to conduct thorough and effective investigations, crucial for ensuring product quality and patient safety.

Subtopics: Investigation Methodologies, Regulatory Compliance, Root Cause Analysis, Documentation, and Reporting.
Readings: We will provide essential reading materials covering FDA and EMA guidelines, as well as industry-standard investigation procedures.
Assignments: The course includes interactive workshops and scenario analysis exercises. Participants will also receive a post-course assignment focusing on the practical application of the skills learned.
We are committed to ensuring that attendees gain a comprehensive understanding of these critical topics. The courses are structured to encourage active participation, ensuring practical and applicable learning outcomes.

The Imperative for Investigations
Risk management principles

  • Understanding the impact of product quality and patient safety
  • Regulatory expectations (FDA, EMA, etc.)
  • Industry standards and guidance (ISO, GMP, etc.)

Investigation Methodologies

  • Overview of systematic investigation processes
  • Introduction to common methodologies (root cause analysis, fishbone diagram, 5 Whys)
  • When and how to use different tools

Regulatory Requirements and Documentation

  • Documentation standards and best practices
  • Maintaining compliance during investigations
  • Case documentation and report writing

Essential Tools for Investigations

  • Data collection and analysis tools
  • Trending and tracking tools
  • Introduction to software aids and their benefits

Interactive Session: Scenario Analysis

  • Participants discuss predefined scenarios
  • Apply methodologies and tools in a guided exercise

Wrap-Up and Preparing for Hands-On Investigations

  • Recap of key takeaways
  • Preview of the next course’s hands-on approach
  • Q&A session and feedback


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