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.
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
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.
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