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India Regional Forum

RQA India ONE!

Charting a sustainable quality movement together...

Speakers

Kamaldeep Singh Grover
VP, QA, Vimta Labs Ltd

Labhu Sanghani
Director - Global QA, Jai Research Foundation

Jayashree Acharya
Associate Director- QBP, ArisGlobal

Jamila Joseph
Senior VP and Head- Innovative Technologies and Clinical Research, Reliance Life Sciences

Kiran Choudhari
Assistant VP - Technology Management, Reliance Industries Ltd

Harish Sankarankutty
Clinical Research Compliance Manager, George Clinical

Rohan Shah
Senior Manager - Quality Assurance, Rhizen Pharmaceuticals SA

Amey Mane
Independent Consultant, Medical Affairs

Sandhya Ravi
Managing Director and Consultant General Surgeon, Prameya Health

Anupama Ramkumar
Principal Consultant & CEO, Arkus Research Pvt Ltd

 

The RQA would like to thank the following organisations for their support:

 

Sparta Systems logo

Platinum Sponsor:  Sparta Systems

Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Our QMS solutions help to lower risk, increase efficiency, and keep consumers safe while allowing manufacturers, suppliers, and distributors to collaborate in a seamless and integrated environment.

Sparta Systems is privately owned and headquartered in Hamilton, New Jersey, USA with offices across Europe and Asia. We support close to 1 million users across 700+ implementations, in more than 30 countries. Companies in life sciences and medical devices, consumer products, discrete manufacturing, and more rely on Sparta Systems.  

 

 

RiverArk logo

Gold Sponsor:  RiverArk

RiverArk is a global boutique consultancy offering services within Quality Assurance, Quality Management and Pharmacovigilance domain. Our clients include Pharmaceutical, Biotech and Medical Device companies. We provide GxP auditing, Quality management consulting, Inspection readiness services, GAP analysis, Risk assessment & mitigation & GxP training.

 

 

 

Programme

8.30 Registration 
9.00 National Anthem
9.05 Welcome
Chair's Opening Remarks
Sharing from RQA Annual Conference
 10.00 Networking break 
10.15 Quality Management System
     - Quality standards - ISO 17025, ISO 15189 and GLP: Where and when are they          relevant for a lab or CRO? 
     - Management review; cost of quality; QbD 

11.00 Debate
Drugs and Cosmetics Act: Challenges in complying with Global Quality Standards while complying with the Law of the Land:
     - GDPR 
     - Clinical trials: Compensation for SAEs, Informed Consent
12.45 Lunch 
 13.45 Good Clinical Practice Case Studies
My perspective on Research Quality as a Clinician and Ethics Committee member  
14.15 Fireside Chat: Data Integrity
     - Impact of inspection findings - USFDA, EU Inspections. 
     - Importance of calibration and site SOPs
     - 21CFR Part 11 compliance: clinical trials, manufacturing and labs.
     - ICH E6 (R2)
15.30 Networking break 
 15.45 Quality in the Information Age
     - Agile in Product development for software Products used by Pharma space,          Computer System Validation of Products, Moving to cloud
     - Blockchain and AI within healthcare - the Impact on Quality 
16.45 RQA in India: Our Way Forward 
 17.30 Close of day 
   
   
   
   
   
   
   

 

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