Release for Supply – TGA

Description

Release for Supply – TGA Training Course

GMP Training Course – Overview

This interactive eLearning course provides a comprehensive understanding of TGA regulatory expectations for Release for Supply (RFS) and Release for Further Processing (RFFP) in the Australian pharmaceutical industry.

The course is designed for professionals involved in the supply of medicinal products to the Australian market, including:
✅ TGA Manufacturing Licence Holders (MAH/Medicine Manufacturers in Australia)
✅ Manufacturers with GMP Clearance from the TGA
✅ Contract Manufacturers & Sponsors of Medicinal Products

This course is based on TGA guidance publications and insights from industry experts, covering key GMP compliance topics such as GMP Agreements, batch traceability, Product Quality Reviews (PQRs), and the responsibilities of the Authorised Person (AP).

Who Should Take This Course?

This GMP training is essential for professionals involved in Release for Supply and GMP compliance in Australia, including:
✅ Authorised Persons (APs) & Qualified Persons (QPs)
✅ Operations & Quality Managers
✅ Pharmaceutical Quality Teams (Self-Inspection, Auditing, Complaints Handling)
✅ TGA Licence Holders & MAHs
✅ Sponsors of Medicines & Clinical Trials (Phase II and beyond)
✅ PQS Personnel Conducting Self-Inspections
✅ Logistics & Batch Traceability Managers
✅ Regulatory & Compliance Teams

Key Learning Topics

This Release for Supply – (TGA GMP Rules) course covers:
📌 TGA Requirements for Release for Supply (RFS) & Release for Further Processing (RFFP)
📌 Medicines Subject to TGA RFS Procedures – Regulatory lists & compliance expectations
📌 GMP Agreements & Contract Manufacturing – Essential content & obligations
📌 Pharmaceutical Quality System (PQS) & RFS Procedures – Integration & oversight
📌 Product Quality Reviews (PQRs) & Stability Programs – Compilation & compliance
📌 Batch Traceability & Recall Responsibilities – Shared obligations & best practices
📌 Complaints, Deviations & CAPA in RFS Context – Investigations & corrective actions
📌 TGA Expectations for Multi-Site Manufacturing – Information-sharing & approvals
📌 Role of the Authorised Person (AP) – Qualifications, training & legal responsibilities
📌 TGA Inspections & Regulatory Oversight for RFS/RFFP

Why This Course is Essential for GMP Compliance

TGA regulations require strict adherence to GMP standards for Release for Supply and Further Processing.

This GMP eLearning course ensures compliance by clarifying:

• Legal obligations for batch certification and stability program monitoring
• Role and signature responsibilities of the Authorised Person (AP)
• Reliance on overseas manufacturers’ PQS & RFS/RFFP procedures
• Delegation of responsibilities & liability considerations

This course provides essential training for pharmaceutical professionals involved in batch release, regulatory compliance, and GMP agreements, helping organisations meet TGA expectations for RFS/RFFP.

Certificate GMP Course for Release for Supply Compliance

• Successful completion of the Final Assessment awards a Certificate of Completion (for GMP training records).
• The course takes approximately 4–5 hours to complete and is available 24/7 for 12 months per user license.
• Ideal for Marketing Authorisation Holders (MAHs), Sponsors, and GMP-cleared manufacturers.
• Note: All prices are in US Dollars.

TGA = Australian Therapeutic Goods Administration