Courses ::
Short Course on Good Manufacturing Practices (GMP) for the Biomedical Industrial (29 & 30 January 2007)

 Date : 29 Jan 2007 to 30 Jan 2007  
 Time : 9.00 am - 5.00 pm  
 Duration : 2 Days  
 Venue : Biomedical Engineering Research Centre, Research Techno Plaza (NTU)  
 CPD Programme : 14 PDUs  
 Organiser : Biochemical Engineering Technical Committee  
 Coordinator : Bobby / Lina  
 Discounted Fees : $ N/A  (Member)
$ N/A  (Non-Member)
 
 Fees : $ 580.00  (Member)
$ 800.00  (Non-Member)
 
 Remarks :
Fees inclusive of 5% GST, course materials and Refreshments.
Discounted Fees: For registration with full payment received before or on 15 January OR companies that send 3 or more participants
Certificate of Attendance will be given to participants with at least 75% attendance
 
 
 
   
 
 
OBJECTIVES
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.


COURSE OUTLINE
Day-1
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

Day-2
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.
 
 
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