GMP Training
C Lim Consulting has conducted client training both locally in Australia and internationally in China, Spain, New Zealand, Singapore, Thailand, Indonesia and Malaysia on all aspects of GMP in pharmaceutical and veterinary products and medical devices.
We provide technical and GMP training courses that cover GMP principles and practices and Quality systems and processes for pharmaceutical products, veterinary products and medical devices. Our services include reviewing, updating and facilitating your training requirements.
GMP training requirements can be tailored to suit and meet either exacting requirements or prepared just to fit for purpose and compliance. We have a library of training modules available for immediate use or to be modified to suit. We can also assist in training your trainers.
Pharmaceutical and Veterinary Products Training
Some training elements in our library for Pharmaceutical products are:
- PQR – Product Quality Review/Annual Product Review
- Inspections/Audits
- GMP audit principles
- Internal audits
- Auditing the Manufacturer
- Audit contractors and suppliers
- Computerised system
- Garments and personal hygiene
- GMP for ALL
- GMP for Cleaner
- GMP for Dispensary
- GMP for Fitter
- GMP for Line Leaders in Packing Hall
- GMP for Line Setter
- GMP for Manufacturing
- GMP for Packing Hall
- GMP for Sampling
- GMP for Warehouse
- GMP for Washroom
- Introduction to GMP and Compliance Management
- Label control
- Microbiological environmental monitoring
- OOS – Out of Specification
- Deviation/Non-conformance Reporting
- Packaging tasks
- Product Stability programme
- Quality Incident and Deviation Report (QIDR)
- QA and QC GMP requirements
- Risk Management/Assessment
- GMP Training requirements
- Train the Trainer
- Product stability requirements
- Validation
- Master Validation Plan
- Analytical method transfer validation
- Analytical method validation
- Cleaning validation
- Computer system validation
- Equipment validation
- Filling validation
- Process (Mixing) validation
- RO water validation
- Validation – general knowledge
- Warehousing
Medical Devices Training
Some training elements in our library for Medical Devices cover:
- Auditing
- Audit the Manufacturer and Assembler
- GMP audit principles
- Multiple site auditing
- Audit contractors and suppliers and contractors
- Computerised system
- Comparative studies of cGMP and ISO 13485
- Conformity assessment
- DOs and DON’Ts during Regulatory audits
- Essential Principles
- Expiry dating for Medical Devices
- Good Distribution Practices (GDP)
- GMDN and UPI
- GMP agreement between Manufacturer/Assembler and Supplier
- ISO 17025
- Life Cycle approach
- Quality Management System (QMS)
- Risk Management
- Surveillance
- Train the Trainer
