The Textiles Committee, Ministry of Textiles, Govt of India is organizing a Two Day Training programme titled “Meeting Challenges of
The Training programme will include
- (i) In depth coverage of market regulations for Masks, Respirators and Coveralls in important export destinations like US & EU.
- (ii) Board overview of medical devices regulations of Australia, Brazil, Canada, Japan, Kenya, South Africa, South Korea and India & ISO 13485 Medical Device QMS requirements
- (iii) Model documentation regarding management system and marketing regulation requirements & contours of 510 K and CE marking dossier making.
- (iv) A dedicated session on actual Testing requirements of PPE.
Please block your slot by paying Registration Fees of Rs. 5000/- (inclusive of 18% GST) by way of bank transfer in favour of “Textiles committee A/c No. 00000034333402348 IFSC SBIN0000290 with email intimation along with payment Reference Number to E-mail ID: trainingcelltc[at]gmail[dot]com
Detailed outline of the Training Programme is as under
|
Day -1 |
Day 2 |
|
I Session |
VI Session - CE Marking |
|
Introduction |
Scope & Purpose |
|
Global PPE / Medical Device Market |
Technical Documentation |
|
Briefing on PPE /Medical devices |
Affixing CE Mark |
|
Briefing on Regulations/Directives/Treaty |
VII Session - Over View of regulations |
|
II Session - EU regulations |
Australia, Brazil, Kenya, South Africa, South Korea, Taiwan |
|
EU - Medical Device Regulation |
VIII Session - Testing |
|
EU - PPE Regulation |
Testing requirements |
|
EUA |
Testing Practical |
|
III Session - ISO 13485 Standards |
IX Session - Risk Assessment and Technical File |
|
Clause No 4,5 & 6 |
Risk Assessment |
|
Clause No 7 & 8 |
Technical File |
|
IV Session - Over View of regulations |
X Session - US Regulations |
|
India |
FDA |
|
Japan, Canada |
NIOSH |
|
V Session - Testing |
EUA |
|
Testing requirements |
|
|
Testing Practical |
|
To book your slot register here
Contact Details for any queries related to this training program is:
Shri. J. D. Barman, Joint Director
E-mail: trainingcelltc[at]gmail[dot]com
Phone: 022-6652 7513/514.
Mobile: 9449041421.