NIB_Noida (17- 19 May 2016)

National Workshop on Laboratory Quality Management System in Biotherapeutics

on

May 17-19 2016 

at

National Institute of Biologicals, NOIDA

  

Program Agenda: Day 1      May 17 2016

       THEME: LQMS - MANAGEMENT AND TECHNICAL REQUIREMENTS

  QUALITY RISK MANAGEMENT 

Time

Title (Learning Objectives)

Presenter

08:30 – 09:00

Registration

NIB and CDSA

09:00 – 09:30

 

 

 

 

 

 

 

 

·         Inaugural Session

·         Floral welcome to Guests

·         Training Objectives, Purpose & Expectations

·         Introduction by Participants

Dr. Renu Jain

Course Coordinator, Scientist-I, Quality Manager, NIB

 

Dr. Sucheta Banerjee Kurundkar

Director Training, CDSA

 

·         Welcome Address

·         Release of Green & Blue Book

 

Dr. Surinder Singh

Director, NIB

Dr. Sudhakar Bangera

COO & Program Director, CDSA

Dr. T. S. Rao

Former Senior Advisor/Scientist H, DBT

Dr. G. N. Singh

DCG(I), CDSCO, New Delhi

09:30 – 10:15

Key Note Address:

LQMS Requirements for accreditation of a Testing Laboratory

Shri. D. S. Tewari

Former Director, NABL; Former Head of National GLP CMA, DST & Chairman, AOIL

10:15 – 10:20

Vote of Thanks

Dr. Reba Chhabra,

Scientist-I, DD(QC) I/c & DD(A) I/c, NIB

10:20 – 11:00

Group Photograph and Networking Tea

11:00 – 11:45

Global expectations on Quality Biotherapeutics

Dr. Rustom Mody

Sr. VP & Head, R&D, Biotech Division, Lupin Ltd.

11:45 – 12:00

 

Challenges of the Market Segment in Biotherapeutics

Dr G. R. Soni

Deputy Director - Quality Control, NIB

12:00 – 12:30

Understanding the role of NCL & Effective implementation of LQMS

Dr. Renu Jain

Scientist I & Quality Manager, NIB

12:30 – 13:30        

·         Quality Concepts: Good to Know 

·         Quality Risk Management

Prof. Arnab Laha

Chairperson, Center for Management of Health Services; Prof of Business Analytics, Quality & Risk Management, IIM Ahmedabad

13:30 – 14:15

Lunch

14:15 – 14:45

LQMS Requirements: Documents & Records

Ms. Y. Madhu

Scientist III & Deputy Quality Manager, NIB

14:45 – 15:00

Laboratory Facility & Safety

Ms. Shalini Tewari

Scientist III & Safety Officer, NIB

15:00 – 16:15

Hands-On Lab Exercise:

·         Sample Management

·         Equipment Management

·         Biosafety Practices & Waste Management

NIB Technical Managers, Analyst & QMU

Team 1: Blood Product Lab

Team 2: Enzyme and Hormone Lab

Team 3: Recombinant Products Lab

16:15 – 16:30

Tea/Coffee Break

16:30 – 17:45

Case Study I: (In laboratory)

·         Policies, Procedures & Records

·         Process Control – Sample Management

Group Task I:

·         Evaluation of Quality Manual for its Adequacy & Batch Testing Record

Moderator: Dr. Sucheta B. Kurundkar, Y Madhu

Reviewer: Quality Manager & Dy. Quality  Manager 

Interactions: NIB Technical Managers, Analyst - Biotherapeutic & QMU  

17:45 – 18:30

Evening Break

18:30 – 19.30

Discussion on Pre-course material

Activities; Terminal Questions; Case Studies

Moderator: Dr. Sucheta B. Kurundkar, Y Madhu

Reviewer: Quality Manager & Dy. Quality  Manager 

Interactions: NIB Technical Managers, Analyst - Biotherapeutic & QMU  

Group Activity:

·         Sharing of Day 1 Lab Experiences

·         Feedback

19:30 onwards

Dinner

 

Program Agenda: Day 2      May 18 2016

          THEME: LQMS:  TECHNICAL REQUIREMENTS; VISION FOR QUALITY IN BIOTHERAPEUTICS;

             ASSURING THE QUALITY OF TEST RESULTS         

 

Time

Title (Learning Objectives)

Presenter

09:00 – 09:30

Recap

Participant Groups

09:30 – 10:00

CDSCO’s Vision for Quality of Biotherapeutics in the Country

Dr. A. Ramkishan

Deputy Drugs Controller (I), CDSCO, New Delhi

10:00 – 10:30

Proficiency Testing (PT) and

Inter Laboratory Comparison (ILC)

Mr. Anuj Bhatnagar

Scientist E, Bureau of Indian Standards

10:30 – 11:00

Internal Quality Control Checks & Handling OOS

Ms. Gurminder Bindra

Scientist III & Technical Manager, NIB

11:00 – 11:15

Tea/Coffee Break

11:15 – 13:15

Hands-On Lab Exercise:

§   Wet lab activity continues

§   Analytical control strategy and expectations

NIB Technical Managers, Analyst & QMU

Team 1: Blood Product Lab

Team 2: Enzyme and Hormone Lab

Team 3: Recombinant Products Lab

13:15 – 14:00

Lunch

14:00 – 14:30

Development of reference standards in rDNA Biotherapeutic products

Dr. Renu Jain,

Scientist- I, Quality Manager, NIB

14:30 – 15:00

Development of reference standards in  Blood products

Dr J. P. Prasad

Scientist II & Technical Manager, NIB

15:00 – 16:00

Hands-On Lab Exercise:

§   Wet lab activity continues

§   Accurate interpretation of Quality Control plans

NIB Technical Managers, Analyst & QMU - Biotherapeutics 

Dr. Sucheta Banerjee Kurundkar, CDSA

16:00 – 16:15

Tea/Coffee Break

16:15 – 16:45

Case Study II:

Process Control: QC for Quantitative Test

Study trend plotting

·              Excel spreadsheet and graphics

Mr. P. S. Chandranand

Junior Scientist & Deputy Quality Manager, NIB

16:45 – 17:10

Case Study III:

·  Process Control: QC for Quantitative Test

·  Relevance of Uncertainty of Measurement in Quality system

Ms. Sudha V. Gopinath

Scientist III & Technical Manager, NIB

17:10 – 18:00

Group Task II:

·         Evaluation of Quality Manual for its Adequacy

·         Reconciliation of Batch Testing Record

Moderator: Dr. Sucheta Banerjee Kurundkar, Gurminder Bindra, PSC Anand

Reviewer: Quality Manager & Deputy Quality  Manager 

Interactions: NIB Technical Managers, Analyst -Biotherapeutic & QMU         

18:00 – 18:30

Evening Break

18:30 – 19:30

Group Task III:

·         Assuring the Quality of test results

Moderator: Dr. Sucheta Banerjee Kurundkar, Gurminder Bindra, PSC Anand

Reviewer: Quality Manager & Deputy Quality  Manager 

Interactions: NIB Technical Managers, Analyst -Biotherapeutic & QMU         

Group Activity:

·         Sharing of Day 2 Lab Experiences

·         Feedback

19:30 Onwards

Dinner

 

Program Agenda: Day 3      May 19 2016

    THEME:    CHALLENGES IN QMS ; DATA INTEGRITY ; WHO PERSPECTIVE IN LQMS 

Time

Title (Learning Objectives)

Presenter

09:00 – 09:30

Recap

Participant Groups

09:30 – 10:15

Challenges in Quality Management  System

Dr. Shaligram Rane

Head QC, Lupin Ltd.

10:15 – 11:00

LIMS & Data Integrity

Mr. Sathya Sekhar Surabhi

MD, Caliber Technologies Ltd.

11:00 – 11:15

Tea/Coffee Break

11:15 – 12:00

Hands-On Lab Exercise:

§   Wet lab activity continues

§  Accurate interpretation of Quality control plans

NIB Technical Managers, Analyst & QMU

Team 1: Blood Product Lab 

Team 2: Enzyme and Hormone Lab

Team 3: Recombinant Products Lab

12:00 – 13:15

WHO Perspective in Laboratory Quality Management System

Dr. Madhur Gupta

Technical Officer, Pharmaceuticals, WHO (India)

13:15 – 14:00

Lunch

14:00 – 15:00

Group Task IV: Continuous Improvement

  • Potential Quality problem
  • CAPA

Dr. Renu Jain, Scientist-I, Quality Manager, NIB

Mr. N. Nanda Gopal, Scientist III & Deputy Quality Manager, NIB

15:00 – 16:00

Exit Assessment

NIB & CDSA Team

16:00 – 16:15

Tea/Coffee Break

16:15 – 17:30

Valedictory  Session

 

Dr. Sucheta Banerjee Kurundkar, CDSA

Dr. Renu Jain, NIB

Dr. Richa Baranwal,

Scientist III & Training Unit I/c, NIB

Closing remarks & Distribution of Certificates

 

Dr. Surinder Singh

Director, NIB

Shri A .B. Ramteke

Former Joint Drugs Controller (India) &

Consultant, Regulatory Affairs, CDSA

17:30 – 18:00

§  Feedback

§  Group  Photos: Participants, Team 1, Team 2 & Team 3