The course aims to provide participants with basic knowledge on Good Manufacturing Practices (GMP) associated with manufacturing of Pharmaceuticals & Medical Devices. The participants will also learn principles of Quality Assurance & Regulatory Compliance associated with Medical Devices.
1. What is GMP? Why is it important in Biomedical Industry?
2. GMP Video-“You will soon feel better”
3. GMP overview vis-à-vis US FDA, ISO & HSA, Singapore GMP guidelines
4. Medical Device classifications
5. Quality Management System
a. 21CFR-210/211 (Pharmaceuticals)
b. 21 CFR-820 (Medical devices)
c. ISO-13485 (Medical devices)
6. GMP Vdeo-“How people contaminate”
7. GMP Design for Buildings & Facilities
a. GMP Layout design
b. Clean Room Classifications
c. Segregation & Cross Contamination Control
d. HVAC (Heating Ventilation & Air-Conditioning) Systems
8. Clean room Environment control
9. Raw Material & Product movement,
a. Good Warehouse Storage & Distribution Practices
b. Packaging/Labeling control
10. GMP Video-“Warehouse/Packaging control”
11. Change Control Procedures & Risk Assessment
12. Handling Non Compliance & Customer Complaints
Group Exercise- (3 hrs)
13. FDA Warning Letters as Case Studies
CV OF SPEAKER
Mr. Sunil Chandiramani has more than 15 years of Industrial experiences with various MNC companies in the field of Pharmaceutical & medical devices manufacturing, such as Glaxo Smithkline, GE Medical devices (Plastics division).He has worked in key functions like Validation, Process optimization, Bulk API Pharmaceutical Plant Commissioning & Medical device New product Engineering & Technology transfer.
During his work with Glaxo Smithkline, Singapore (Antibiotics plant) he was directly involved with commissioning of Expanded Antibiotics Bulk API manufacturing which includes: Validation Protocol development (VMP, IQ, OQ, PQ, & PV) & execution, Developing SOP’s for plant operators, Training operators/Supervisors on GMP, Risk Analysis & Change Control management. He has also worked on various Plant improvement projects like Debottlenecking of Low temperature cooling system, & Solvent stripper process commissioning and optimization.He is also a certified Six Sigma Black Belt (GE Certified) and he is currently working with a biomedical MNC responsible for New product introduction & Technology transfer.