PDA India Chapter: Supply Chain Resilience & Quality Management Maturity
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
The SCR & QMM program goes beyond traditional Good Manufacturing Practices (GMP) by embracing anticipatory actions. These proactive measures aim to prevent issues before they arise, ensuring a future-proof and resilient supply chain. QMM fosters a culture where quality is a primary focus, integrating advanced management practices, continuous improvement, and risk minimization into every aspect of the business, by all the departments that weave their interdisciplinary elements.
Join us at our upcoming workshop and conference on Quality Management Maturity (QMM) & Supply Chain Resilience. Discover how you can participate in transforming your company's quality practices and secure a robust supply chain of materials while keeping the talent pipeline engaged and empowered.
The Workshop will be held on 18 September, 2024 and the Conference will be held on 19-20 September, 2024
Both events will take place at the ITC Gardenia, Bengaluru
Target Audience
- CEOs & Executive Leaders
- R&D & Technology Transfer Leaders
- Human Resource Leaders
- Operations & Production Heads
- Engineering Heads
- Quality Assurance Heads
- Supply Chain- Procurement & Planning Heads
Additional Information
Who should attend by Departments- Leads of Quality Assurance
- Leads of Supply Chain
- Leads of Operations- Manufacturing
- Leads of Research & Development
- Leads of Facility, Engineering and Maintenance
- Leads of Human Resource
- Leads of Technology Transfer
- Leads of Regulatory Affairs
Networking Opportunities
Wednesday, 18 September 2024
- Morning refreshment break in the Exhibit Area
- Networking Lunch break in the Exhibit Area
- Afternoon refreshment break in the Exhibit Area
Thursday, 19 September 2024
- Morning refreshment break in the Exhibit Area
- Networking Lunch break in the Exhibit Area
- Afternoon refreshment break in the Exhibit Area
Friday, 20 September 2024
- Morning refreshment break in the Exhibit Area
- Networking Lunch break in the Exhibit Area
- Afternoon refreshment break in the Exhibit Area
Exhibit & Sponsorship
Interested in becoming an exhibitor or sponsor? To learn about opportunities and benefits write to: pdaindiachapter@gmail.com
Contact
Registration, Exhibition and Sponsorship questions, please contact Biny Joseph at: pdaindiachapter@gmail.com.
Registration
Download Registration FormHighlighted Presenters
Key Presenters
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Indrajit Bose
Glenmark Pharmaceuticals Ltd.
President & Chief Quality Officer
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Michael Cutter
Senior Consultant
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Jacquin Jones
US FDA, India Office
International Relations Specialist
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Bhaskar Krishna
Maiva Pharma Pvt. Ltd.
Managing Director
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Geena Malhotra
Signet Excipients
Managing Director
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Reem Malki
Sun Pharmaceutical Industries Ltd.
EVP, Chief Quality Officer
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Niraj Mehta, PhD
MSD
Executive Director, Head of GQ Strategic Programs and Regulatory Intelligence
Read Bio -
Ravi Menon
Serum Institute of India Pvt Ltd.
Director Production (Fill finish)
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Ranjana B. Pathak, BSc, MBA, DHA
Lupin
Chief Quality Officer
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Vijayasarathi Ramaswami
Cipla Ltd
Global Head of Quality
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M. Gopi Reddy
Sun Pharmaceutical Industries Ltd.
Vice President, Head- Corporate Quality Compliance and CQA
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Constance L. Richard-Math
US FDA, India Office
Supervisory Consumer Safety Officer
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Dhruv Shah
US FDA, India Office
Senior Technical Advisor
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Gregory Smith
US FDA, India Office
Country Director
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Abhay Kumar Srivastava
Mankind Pharma
President, Operations
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Krishna Venkatesh
Dr. Reddy's Laboratories
Global Head Quality & Pharmacovigilance
Agenda
Discover What's Happening Each Day
September 18, 2024
09:00am - 09:20am | Opening Remarks
09:20am - 10:00am | Intention of Workshop: Setting Expectations & Outcome Mapping
10:00am - 11:00am | Case study 1 & Group Work Time: Operational Efficiencies
11:00am - 11:30am | Break
11:30am - 1:00pm | Debrief of Case Studies: Take Home Messages and Creation of a Checklist from the QMM Protocol
1:00pm - 2:00pm | Lunch
2:00pm - 3:00pm | Case study 2 & Group Work Time: Fit for Purpose Case Studies (1) Aging Technology, Equipment, Facility and Workforce (2) Creating & Casacading fGMPs (3) Investing for Quality
3:00pm - 3:30pm | Break
3:30pm - 5:00pm | Debrief of Case Studies: Take Home Messages and Creation of a Checklist from the QMM Protocol
5:00pm - 6:00pm | Consolidation and Overview of the QMM Messages: Q&A with Take Home Messages of Enhancing Engagement With and Between all Workgroups in Organizations; Discuss FTS Clauses and Metrics of assessment of QMM
September 19, 2024
07:30am - 08:30am | Registration & Formalities
08:30am - 08:45am | Opening Keynote, Address by Member of PDA Chapter, Chair Board Of Directors/PDA India Chapter
08:45am - 9:15am | Introduction, Deputy Drug Controller, CDSCO
09:15am - 9:30am | Introduction to Conference, Co-Leads/Planning Committee Members
9:30am - 9:45am | Introduction to the Activities of the US FDA India Office, US FDA India Office
9:45am - 10:30am | Overview of the FDA QMM Program, US FDA QMM Program
10:30am - 10:45am | Networking & Tea Break
10:45am - 11:30am | Session 1: Leadership & Management Commitment to Quality - Expectations for Building blocks of the organization: Focus area-Product Quality for Supply Chain Resilience
11:30am - 11:50am | Session 2: Leadership & Management Commitment to Quality (cont.) - The How, the What and the Why of Management Review
11:50am - 12:20pm | Session 3: Business Continuity - QMM and Business Continuity
12:20pm - 12:45am | Session 4: Business Continuity (cont.) Operating Strategy - Forecasts versus demands- Challenges for Materials & Management: Case Study with Futuristic Practices
12:45pm - 1:30pm | Panel Discussions: Leadership & Management Commitment to Quality & Business Continuity - Panel Discussions with Speakers and Special Invitees, Q&A from Audience
1:30pm - 2:30pm | Networking and Lunch Break
2:30pm - 3:10pm | Session 5: Technical Excellence: Fit For Purpose: Case study 1- Assessing the Blips and Outcome- Vaccine Manufacturing Versus Classical Pharmaceutical Manufacturing
3:10pm - 3:50pm | Session 6: Technical Excellence (cont.): Fit For Purpose: Case study 2: Moving from cGMP to fGMP- a look into the horizon of the future of managing product, process and services for SC resilience
3:50pm - 4:30pm | Session 7: Technical Excellence (cont.): Fit For Purpose: Case study 3: Investing for Quality- Dynamics for Mobility-From Uncertainty to Certainty
4:30pm - 4:45pm | Networking & Tea Break
4:45pm - 5:15pm | Session 8: Technical Excellence (cont.): QMM & Technical Excellence
5:15pm - 5:45pm | Q&A: Taking Technical Excellence Notches Higher
5:45pm - 6:00pm | Summary of the Day, PDA India Chapter Officer
September 20, 2024
09:00am - 09:10am | Recap, Co-Chairs/Planning Committee Members
09:10am - 09:50am | Session 9: Advanced PQS & SCM Resilience - (1) Components of PQS Tied up to SCM Resilience; (2) Components of an Advanced PQS Tied to Operations
09:50am - 10:20am | Session 10: Advanced PQS & SCM Resilience (cont.) - Changing the Paradigm of Change Management for QMM
10:20am - 11:00am | Panel Discussions - Sessions 9 & 10
11:00am - 11:15am | Networking and Tea Break
11:15am - 11:45am | Session 11: Employee Empowerment & Engagement - Structuring the Organization with Roles and Functions that Fit- Optimization of Human Capital to Leverage the Physical Capital
11:45am - 12:45pm | Session 12: Employee Empowerment & Engagement (cont.)- Best Practices from Other Industries: Methods to Facilitate 3Es: Employee Empowerment & Engagement
12:45pm - 1:45pm | Networking & Lunch Break
1:45pm - 2:45pm | Session 13: Employee Empowerment & Engagement (cont.)- Assessing the Employee engagement- Establishing & Measuring indicators and interventions; Management Roles- Tools & Techniques for Enhancing Employee Engagement
2:45pm - 3:15pm | Q&A for Sessions 11, 12 & 13
3:15pm - 4:15pm | Audience Speak Listing Activities: Blending Concepts of QMM to SCRBlending Concepts of QMM to SCR
4:15pm - 4:30pm | Networking & Tea Break
4:30pm - 5:15pm | Session 14, Revised Technical Report 68- Avenues for Adoption of Practices for the Industry
5:15pm - 5:45pm | Closure to Day, PDA India Chapter Officers
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
ITC Gardenia
1 Residency Rd.Bengaluru, India 560025
Phone: 080 2211 9898
Reservation Instructions
For information on special room rates please contact: pdaindiachapter@gmail.com
ITC Gardenia
Set in the bustling commercial heart of Bengaluru, Karnataka ITC Gardenia, a Luxury Collection Hotel, Bengaluru offers effortless access to key Bengaluru business districts and IT hubs. Experience a world of sophisticated luxury , where you can unwind by the outdoor pool or indulge in pampering treatments at Kaya Kalp - The Spa. Savor exquisite Indian and international cuisine at our award-winning restaurants, or host grand events in their state-of-the-art meeting facilities.
How to Get Here
Registration
Pricing Options
Regular Registration fees/person: INR 59,000 ( Including 18% GST)
Presenters
Meet the Experts
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Rajshekhar .
Deputy Drugs Controller (India)
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Yogish Arora
HR Anexi
Director
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Denyse D. Baker, PE, RAC
Eli Lilly and Company
Associate VP, Global Quality External Engagement
Read Bio -
Michael Cutter
Senior Consultant
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Jennifer Huttington
CDER, US FDA
Regulatory Specialist, OQS
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Bhaskar Krishna
Maiva Pharma Pvt. Ltd.
Managing Director
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Geena Malhotra
Signet Excipients
Managing Director
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Reem Malki
Sun Pharmaceutical Industries Ltd.
EVP, Chief Quality Officer
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Niraj Mehta, PhD
MSD
Executive Director, Head of GQ Strategic Programs and Regulatory Intelligence
Read Bio -
Ravi Menon
Serum Institute of India Pvt Ltd.
Director Production (Fill finish)
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Ranjana B. Pathak, BSc, MBA, DHA
Lupin
Chief Quality Officer
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Chella Pandian Pitchai
Biocon Biologics
Global Head - Diversity, Equity & Inclusion
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Nandini Rakala
CDER, US FDA
Visiting Associate, OQS
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Sandeep Raktate
Amneal Pharmaceuticals
Presidents, Operations
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K.V.S. Ram Rao
Granules India Lt.
Ceo & Joint Managing Director
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Emma Ramnarine, PhD
Boehringer-Ingelheim
Executive Director, Product Management & Development Operations
Read Bio -
Carmen Amelia Rodriguez Hernandez
WHO
Team Lead, Vaccines PQ
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Anshul Saxena
Life Sciences Sector Skill Development Council
VP Apprenticeship, Ecosystem Development - Govt. & Industry
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Ran Bahadur Singh
GSK
Head, Supplier Quality Audit & Compliance, South Asia, Middle East, Africa
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Gregory Smith
US FDA, India Office
Country Director
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N.S. Sreenath, PhD
Biovet
CEO
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Abhay Kumar Srivastava
Mankind Pharma
President, Operations
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Eric Twum
CDER, US FDA
Regulatory Specialist, OQS
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Krishna Venkatesh
Dr. Reddy's Laboratories
Global Head Quality & Pharmacovigilance
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Jignesh Vora
Accenture Strategy and Consulting
Managing Director (Partner)
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Srivatsa Yajaman
Streamline Consulting and Analytics
Owner
Sponsors
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