Description, Duration and Outcome of the Workshop in Collaboration with CDL on CDSCO Advanced Training on Evaluation of CMC Module III of CTD and

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1 Description, Duration and Outcome of the Workshop in Collaboration with CDL on CDSCO Advanced Training on Evaluation of CMC Module III of CTD and inspection of vaccine manufacturing units as per cgmp norms on 7th- 8th March, 2014 at CDL Kasauli

2 CDSCO planned two days CDSCO Advanced Training on Evaluation of CMC Module III of CTD and inspection of vaccines manufacturing as per cgmp norms on 7th- 8th March, 2014 at CDL Kasauli in collaboration and with technical support of CDL, Kasauli. The workshop was focused on CDSCO procedure of review of CMC Module III. The workshops had been funded by Government of India with partial logistic support from WHO country office. The training was imparted by experts from CDSCO HQ and CDL Kasauli.

3 OBJECTIVES OF THE WORKSHOP The primary objective of the workshop is to enhance the capacities and skills required for evaluation of vaccine dossier for marketing authorization by CDSCO, NCL reviewers (CDL Kasauli), NDAC experts. The other objectives of this workshop are as given below: To impart basic knowledge on components of CMC (Chemistry, manufacturing and control). To improve the skills in conducting competent and efficient GMP inspections of vaccine manufacturing facilities using risk management approach of all regulatory Inspectors supervising manufacturing. The NRA IDP will be updated for regulatory inspection function.

4 SPEAKERS/ RESOUECE PERSONS FOR THE WORKSHOP

5 AGENDA FOR THE WORKSHOP DAY- 1 Time Topic/ Presenter 09:30-10:00 Registration, welcoming of the facilitators & participants, & introduction, Group Photo - CDL 10:00-10:30 Group Photo and Pre course questionnaire - Mrs. Kiran Pandey 10:30-11:00 General Overview of CDSCO procedure of Marketing authorization Dr. Ramkishan, DDC(I) 11:00-11:30 Tea Break 11:30-12:00 General Overview of CDSCO procedure of review of CMC Module III - Ms Swati Srivastava, ADC(I) :00 Vaccine Basics - Mr. Sunil Goel 13:00-14:00 Lunch Break 14:00-14:10 Warm Up - Mr. Sunil Goel 14:10-14:40 Conjugate Vaccines - Mr. Sunil Goel 14:40-15:10 Viral Vaccines-Safety Aspects - Mr. Sushil Sahu 15:10-15:30 Tea Break 15:30-16:30 16:30-17:30 Inspection of Vaccines Bulk Manufacturing (Bacterial/ Viral/ Recombinant) - Ms. Rubina Bose Group Exercise I Review of CMC Module III - CDL

6 DAY- 2 Time Topic/ Presenter 09:00-09:10 09:10-10:45 10:45-11:00 Tea Break 11:00 12:30 Warm Up - CDL Group Exercise I continued Review of CMC Module III - CDL Group Exercise II Review of CMC Module III - CDL 12:30-13:15 Lunch Break 13:15-13:25 13:25-14:45 14:45-15:00 15:00-15:15 Tea Break Warm Up - CDL Group Exercise II continued Review of CMC Module III - VDL Post Course Questionnare - Mrs. Kiran Pandey 15:15-16:15 Group Presentation and Feedback 16:15-16:30- Closing

7 GROUP PHOTOGRAPH DURING THE OPENING CEREMONY OF WORKSHOP AT KASAULI

8 INTRODUCTION AND DESCRIPTION OF THE TRAINING HELD The CDSCO Advanced Training on Evaluation of CMC Module III of CTD and inspection of vaccines manufacturing as per cgmp norms was completed at CDL Kasauli on 7th- 8th March, The workshop was started with the opening address by Mr. Sunil Goel, Technical Officer CDL, Kasauli by welcoming participants and introduction of all experts to the participants. Mr. Sunil Goel thanked all the Experts for joining the workshop to share their knowledge and explained background of the workshop and meticulous planning of the training in the form of lectures by experts. On behalf of CDL Kasauli, Mrs Kiran Pandey, Deputy Assistant Director, CDL, Kasauli has welcomed all the experts and participants and addressed the importance of this workshop.

9 The list of participants is as per the table given below S. No Name Designation Organization / Division 1 Mr. Saurabh Garg CDSCO(HQ) Drugs Inspector 2 Mr. Rakesh Negi CDSCO(HQ) Drugs Inspector 3 Mr. Devendra Nath CDSCO(HQ) Drugs Inspector 4 Mr. Fahim Khan CDSCO(HQ) Drugs Inspector 5 Mr. Rahul Panwar CDSCO(HQ) Drugs Inspector 6 Mr. Ankur Bansal CDSCO(HQ) Drugs Inspector 7 Mr. P.Manavalan CDSCO Sub-zonal Office Chandigarh Drugs Inspector 8 Mr. Rahul S Shakhapure CDSCO(Zonal Office Hyderabad) Drugs Inspector 9 Mr. Pravin Jagtap CDSCO(WZ) Drugs Inspector 10 Mr. Virendra Singh CDSCO Zonal office Ahmedabad Drugs Inspector 11 Mr. Ashok Kumar Yadav CDSCO(WZ) Drugs Inspector

10 S. No Name Designation Organization / Division 12 Mr. Shiv Kumar CDSCO(EZ) Drugs Inspector 13 Mr. Amol Eknath Kandekar CDSCO(HQ) Drugs Inspector 14 Mr. Popat D. Thorat CDSCO(HQ) Drugs Inspector 15 Ms. M. Shakuntala CDSCO (SZ) Drugs Inspector 16 Dr. Rajesh Sharma NIB, Noida Scientist 17 Dr. Renu Jain NIB, Noida Scientist 18 Smt. Shalini Tewari NIB, Noida Scientist 19 Smt. E. Madhu NIB, Noida Scientist 20 Dr. Richa Barnwal NIB, Noida Scientist 21 Mr. Sumir Rai Bhalla CDL Kasauli Scientist 22 Mrs. Sameera Rawat CDL Kasauli Technical Supervisor

11 S. No Name Designation Organization / Division 23 Mr. Vivek Bansal CDL Kasauli Technical Supervisor 24 Mr. Devinder Kumar CDL Kasauli Technical Supervisor 25 Mr. Dev. Barthwal CDL Kasauli Technical Supervisor 26 Mr. Sachin Sood CDL Kasauli Technical Supervisor 27 Mr. Suresh Kumar CDL Kasauli Technical Supervisor 28 Mr.Jasvinder Singh CDL Kasauli Technical Supervisor 29 Mrs. Seema Sood CDL Kasauli Technical Supervisor 30 Ms Suchita Sharma CDL Kasauli Technical Supervisor 31 Mr. Satnam Singh CDL Kasauli Technical Supervisor 32 Mr. Dhani Ram CDL Kasauli Technical Supervisor

12 MR SUNIL GOEL WELCOMING THE FACILITATORS AND PARTICIPANTS

13 Day-wise proceeding of the workshop is as follows: Day One Before starting the presentations the pre course evaluation was conducted as a test of their basic knowledge on Vaccines and different modules of CMC prior to the workshop. Various agenda topics deliberated and discussed by the speakers of the workshop. After completion of presentations all the participants was divided into 7 groups and assigned Group Exercise 1 on Review of CMC Module III to each group. Day Two Group Exercise I on Review of CMC Module III was continued up to the tea session. Post tea session started with Group Exercise II on Review of CMC Module III for all the groups. After completion of Group Exercise II, post course questionnaire was given to all the participants to evaluate the effectiveness of the workshop and the knowledge gained by the participants. All the groups prepared presentations for their finding during the review of group exercise I and II and presentation on observations was made by each group effectively. There was interactive discussion amongst all the groups during the presentations and valuable input was made by the speakers/ experts. Vote of thanks and conclusion of the workshop was done by Mr. Sunil Goel, CDL Kasauli.

14 DR. A. RAMKISHAN MRS. SWATI SRIVASTAVA MRS. KIRAN PANDEY MR. SUSHIL SAHU PRESENTATIONS BY DIFFERENT SPEAKERS DURING WORKSHOP

15 MRS. RUBINA BOSE, ADC(I), DURING PRESENTATION

16 PARTICIPANTS DURING THE PRESENTATION

17 DIFFERENT GROUPS REVIEWING CMC MODULES

18 OUTCOME: Knowledge imparted on vaccine basics i.e. type of vaccines and production procedure. Knowledge imparted on different modules of CTD. Knowledge on Guidance for Industry Requirements for permission of New Drug Approval. Knowledge on General Requirements of Viral Vaccine production. Knowledge on regulatory inspection process in India and the mechanisms used by CDSCO to enforce GMP to vaccine manufacturers.

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