Aims and Objectives:

This course introduces GMP and auditing requirements for clinical trials. On completion of this course you will be able to:

  • Understand and interpret international regulations and protocols for Good Clinical Practice (GCP) activities.
  • State FDA and TGA requirements for GCP.
  • State principles of New Product Development and GxP Regulations.
  • State requirements for GCP protocols required for clinical programs, including data collection and records control.
  • Audit Clinical Protocols and Trials.

Content:

This course consists of 5 modules or topics:

1 Introduction to GCP

This module introduces international regulations and protocols for GCP activities, FDA and TGA requirements.

  • Have an appreciation for international regulations and protocols for GCP activities.
  • Briefly explain Phases I, II, III and IV.
  • Have an appreciation for FDA and TGA requirements.

2 New Product Development and GxP Regulations

This module gives an overview of project management in the context of new product development and GxP regulations.

  • Discuss the CTN/CTX and IND Approval schemes.
  • Have an overview of project management for product development and clinical programs.
  • Demonstrate key checkpoints in product development for clinical trials.

3 Clinical Programs – Protocols, Recruitment, Initiation, Assessment & Management

This module details protocols etc. required for clinical programs including data collection and records control.

  • State the key requirements of GCP
  • Document what is required for:
  • Data collection
  • Records control
  • QA reviews and
  • Storage/archiving.

4 Product Manufacture and Distribution

This module introduces requirements for clinical material manufacture:

  • List the key GMP requirements for the manufacture of materials for clinical trials.
  • Define the terms “blinding” and “randomisation” as they relate to clinical trials.
  • List the key GMP requirements for the labelling and packaging of materials for clinical trials.
  • Identify potential sources of errors and mix ups in the distribution of material for clinical trials and list strategies to prevent their occurrence.

5 Auditing Clinical Protocols and Trials

This module introduces auditing requirements for clinical trials.

  • Vendor Qualification.
  • Prepare patient report reviews.
  • Purpose and requirements of Clinical Quality Assurance (CQA).
  • CQA activities before, during and after a Clinical Site Audit.
  • FDA Inspection: What to expect and common audit findings.

Format and Course Length: 

The 3-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.

Scheduled sessions run from 9am to 5pm unless otherwise specified.

Call us or click here to e-mail us and register your interest.

 

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