Foundations of Investigation in Pharma and Medical Device Industries

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

Understanding the importance and impact of investigations on product quality and patient safety.
Learning systematic methodologies for conducting investigations.
Gaining knowledge of the regulatory requirements and best practices for documentation.
Developing skills in using various investigative tools and techniques.
Enhancing the ability to analyze and interpret investigation findings for corrective actions.

Quality Assurance and Compliance professionals
Regulatory Affairs specialists
Production and Operations staff in pharma and medical device sectors
Laboratory and investigation team members
Auditors and Consultants in the pharmaceutical and medical device industries

Registration Form

Course title: Foundations of Investigation in Pharma and Medical Device Industries

Information

Live online training via Zoom;
View presenter and interact with attendees;
Certificate will be sent after completing the course;
Before attending the course, you will be sent the meeting ID, passcode and link for the course.

Registration Fee

Regular Registration: $780 (Until 03 Jun 2024)

Late Registration: $900 (Until 17 Jun 2024)

$900

Per person (Tax included)

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