GMP Code: Blood and Tissue Products (TGA Regulations)

Description

TGA Regulations: Blood and Tissue Products including Human Blood Components/Plasmas and Cellular Therapy Products

Blood & Tissue Products: Course Overview

• This online GMP compliance training course provides a comprehensive understanding of Australian TGA regulatory requirements for blood, blood components, plasma, and tissue products, including cellular therapy products.
• While the TGA follows the PIC/S GMP Guide for blood and tissue products, the TGA has also established specific regulations for these high-risk products to ensure their safety, efficacy, and supply chain security.
• Participants will gain insights into TGA guidelines, GMP expectations, and best practices for compliance.

Key Learning Topics

• Overview of the TGA’s Australian Code of GMP for Human Blood and Tissue Products
• GMP requirements for the collection, processing, storage, and distribution of blood and tissue products
• Donor screening, recordkeeping, and batch traceability compliance
• Quality assurance and risk mitigation strategies
• TGA audit expectations and industry best practices
• Other applicable regulations to explore where relevant, e.g., Annex 2A, Annex 2B, Annex 13, and Annex 14

Who Should Complete this Course?

This course is ideal for professionals involved in the collection, processing, testing, storage, transport, and distribution of blood and tissue products in Australia.

This online course is suitable for professionals of all levels, e.g.:
✅ Employees responsible for blood and tissue product manufacturing and compliance
✅ Research personnel (blood and tissue products or derivatives)
✅ Personnel handling human blood and tissue in GMP/GxP environments
✅ TGA-audited companies and regulatory compliance teams
✅ Suppliers, subcontractors, and logistics personnel working with these products
✅ Clinical trial sponsors and personnel involved with blood-based products

Learn Essential Blood and Tissue Product Regulations

This eLearning course will help you and your team to understand their regulatory compliance responsibilities relevant to:

 

📌 TGA Code of GMP for Human Blood, Blood Components, Human Tissues & Cellular Therapy Products
📌 Therapeutic Goods Orders (TGOs) relevant to blood and tissue products
📌 PIC/S GMP Annexes & ATMP regulations for biologics and blood-derived products
📌 GMP guidance and legal requirements for donor screening, product storage, and batch recordkeeping

Blood & Tissue Product Case Studies and Regulatory Insights

• Real-world case studies highlighting key compliance challenges and regulatory findings
• Case study analysis to understand regulatory enforcement trends
• Best practices for ensuring compliance and passing TGA GMP compliance audits

Flexible Online Learning Format

This self-paced eLearning course allows you to:
✔️ Access course materials anytime, anywhere (valid for 12 months from the date of purchase)
✔️ Learn at your own pace with real-world case studies & warning letter examples
✔️ Combine GMP eLearning options with instructor-led training options (virtual or onsite, where available)

Visit PharmOut for details or for assistance with cleanroom facility designs, upgrades, process validation, computerised systems validation, and facilitated training options for large teams.

Blood & Tissue Products GMP Training Certificate

Upon successful completion of this course, including the Final Assessment, you will receive a Blood & Tissue Products (GMP) Training Certificate of Completion.

This course certificate:

• Should be included in your personnel records, e.g., Regulatory Compliance & GMP training program files
• Can be attached to job applications or promotion applications/qualifications
• Provides proof that you’ve been trained in GMP regulations and best practices
• Can help support your career development in regulated industries

It is recommended to review relevant GMP regulations after completing the course. To improve your understanding of GMP rules and aid retenton, read the regulations both BEFORE and AFTER completing this course. 

How to complete this course.

This Blood and Tissue Products regulatory compliance training is available fully online (24/7 access)

• Add the course to your basket and complete your purchase (fees are in US dollars)
• One user/per licence purchase (12 months’ access)
• Check your emails (search all folders) for log-in instructions approximately 5 minutes after your order is finalised
• Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”

Can anyone take this GxP/GMP online training course?

• Yes, anyone can complete this course upon purchase and registration
• This course is suitable for a wide range of employees in the Pharmaceutical and Medical Device industries
• It is also suitable for individuals who work with blood and tissue involved in Clinical Trials

Resources & Additional GMP eLearning Courses

Explore additional GMP training courses, including:

• Sterile Final Dosage
• Supplier Qualification
• Batch Release Training
• 70+ GMP education modules for compliance training

Click here to explore more GMP eLearning courses!

GMP Training Programs

GxP Regulatory Compliance Training 

Training course bundles are also available if you want to mix and match courses.

• You can purchase this course individually and/or in a training bundle.
• Purchasing several courses at one time helps you save on your training budget.
• Click the bundles tab on the page you’re on to explore those options or enter ‘bundle’ into the search box on this page.

If you need to train large numbers of employees (e.g. 50 to 1000 employees, or more), contact us for a custom quote.

• Bundled GMP training options for large groups of personnel permits Training Program administrators to:
  • ‘Mix and match’ standard GMP compliance training courses.
  • Assign courses to different employees when required.
  • Provide ‘just in time’ GMP training and annual GMP compliance refresher training (self-paced)/

Note: All course prices are in US dollars.

Review other popular GMP education topics on the GMP training store pages