PDA India Chapter: Supply Chain Resilience & Quality Management Maturity
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Group Registration
Registration
Download Registration FormThe 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.
Regular Registration fees/person: INR 59,000 ( Including 18% GST)
Day 1
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
Day 2
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
Day 3
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
Featured Presenters
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Indrajit Bose
President & Chief Quality Officer, Glenmark Pharmaceuticals Ltd.
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Michael Cutter
Senior Consultant
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Jacquin Jones
International Relations Specialist, US FDA, India Office
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Bhaskar Krishna
Managing Director, Maiva Pharma Pvt. Ltd.
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Ivy Louis, M.Pharm MBA(HRM)
Founder, Director, Vienni Training & Consulting LLP
Read Bio
Ivy Louis, M.Pharm MBA(HRM)
Vienni Training & Consulting LLP
Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management. Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education. Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member and has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also an active member of the Science Advisory Board and currently holds a position as Member-Board of Directors for PDA Inc.
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Geena Malhotra
Managing Director, Signet Excipients
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Reem Malki
EVP, Chief Quality Officer, Sun Pharmaceutical Industries Ltd.
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Niraj Mehta, PhD
Executive Director, Head of GQ Strategic Programs and Regulatory Intelligence, MSD
Read Bio
Niraj Mehta, PhD
MSD
Dr. Mehta has been with Merck for three years and leads the Global Quality Strategic Programs and Regulatory Intelligence team within Merck’s Manufacturing Division. The team is responsible for the management of external policy and advocacy, and execution of processes to ensure Merck’s Quality Compliance excellence.
Prior to joining Merck, he spent 10 years at the U.S. FDA in various roles including Senior Pharmacologist within the Center for Drug Evaluation and Research (CDER). His last role was within FDA’s Office of Commissioner where he helped facilitate the adoption and implementation of the US-EU Mutual Recognition Agreement. He holds a Ph.D. in Pharmacology and Molecular Sciences from the Johns Hopkins School of Medicine.
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Ravi Menon
Director Production (Fill finish), Serum Institute of India Pvt Ltd.
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Ranjana B. Pathak, BSc, MBA, DHA
Chief Quality Officer, Lupin
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Vijayasarathi Ramaswami
Global Head of Quality, Cipla Ltd
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M. Gopi Reddy
Vice President, Head- Corporate Quality Compliance and CQA, Sun Pharmaceutical Industries Ltd.
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Constance L. Richard-Math
Supervisory Consumer Safety Officer, US FDA, India Office
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Dhruv Shah
Senior Technical Advisor, US FDA, India Office
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Vishal Sharma, MS
Co-Founder, Director, Vienni Training & Consulting LLP
Read Bio
Vishal Sharma, MS
Vienni Training & Consulting LLP
Masters in Microbiology (M.Sc) with over two decades of experience in working in pharmaceutical manufacturing companies & consulting. Six Sigma green belt certified by Indian Institute of Statistics. Participates in and leads the initiatives of Parenteral Drug Association India Chapter as a founding member, a chapter board member and step up as PDA India Chapter President in January 2022.
- Volunteer for PDA Journal Science & Technology as reviewer for articles on sterilization and sterility assurance.
- Member of a PDA Task force, contributing to the points to consider (PTC) for remote inspections/audits. PTC's are peer reviewed by various global regulatory agencies.
Exposure to and experience in the quality control/assurance functions in Microbiology & with exposure of facing regulatory audits, exposure to sterile manufacturing for small molecules & Sterile API, designing & validating aspects/sterilization processes for products for global market. Handled the validation laboratory establishments & functioning for filtration & validation, excels in trouble shooting, especially in the aseptic area, microbiology & sterilization using statistical approaches. Consults, trains and educates sterile parenteral manufacturing teams, engaged in operations.
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Gregory Smith
Country Director, US FDA, India Office
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Abhay Kumar Srivastava
President, Operations, Mankind Pharma
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Krishna Venkatesh
Global Head Quality & Pharmacovigilance, Dr. Reddy's Laboratories
Presenters
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Rajshekhar .
Deputy Drugs Controller (India)
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Yogish Arora
Director, HR Anexi
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Read BioDenyse D. Baker, PE, RAC
Associate VP, Global Quality External Engagement, Eli Lilly and Company
Denyse D. Baker, PE, RAC
Eli Lilly and Company
Denyse Baker is the Associate Vice President, External Engagement and Advocacy, for the Global Quality Compliance organization at Eli Lilly. She is passionate about connecting and collaborating to develop science-based regulation and organizational quality culture as to enable production of high quality products for patients. Denyse has a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Denyse returned to Lilly in December 2022 following work experience with the US FDA, the Parenteral Drug Association, and AstraZeneca. She is a member of the Global Quality Management WG at PhRMA, Vice-Chair of PDA’s Regulatory and Quality Advisory Board, Co-leader of the PDA Quality Management Maturity Task Force, and secretary to the FDA Alumni Association Board of Directors. Denyse holds a B.S. in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and earned RAC certifications in US and EU Reg Affairs. -
Michael Cutter
Senior Consultant
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Jennifer Huttington
Regulatory Specialist, OQS, CDER, US FDA
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Bhaskar Krishna
Managing Director, Maiva Pharma Pvt. Ltd.
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Geena Malhotra
Managing Director, Signet Excipients
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Reem Malki
EVP, Chief Quality Officer, Sun Pharmaceutical Industries Ltd.
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Read Bio
Niraj Mehta, PhD
Executive Director, Head of GQ Strategic Programs and Regulatory Intelligence, MSD
Niraj Mehta, PhD
MSD
Dr. Mehta has been with Merck for three years and leads the Global Quality Strategic Programs and Regulatory Intelligence team within Merck’s Manufacturing Division. The team is responsible for the management of external policy and advocacy, and execution of processes to ensure Merck’s Quality Compliance excellence.
Prior to joining Merck, he spent 10 years at the U.S. FDA in various roles including Senior Pharmacologist within the Center for Drug Evaluation and Research (CDER). His last role was within FDA’s Office of Commissioner where he helped facilitate the adoption and implementation of the US-EU Mutual Recognition Agreement. He holds a Ph.D. in Pharmacology and Molecular Sciences from the Johns Hopkins School of Medicine.
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Ravi Menon
Director Production (Fill finish), Serum Institute of India Pvt Ltd.
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Ranjana B. Pathak, BSc, MBA, DHA
Chief Quality Officer, Lupin
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Chella Pandian Pitchai
Global Head - Diversity, Equity & Inclusion, Biocon Biologics
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Nandini Rakala
Visiting Associate, OQS, CDER, US FDA
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Sandeep Raktate
Presidents, Operations, Amneal Pharmaceuticals
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K.V.S. Ram Rao
Ceo & Joint Managing Director, Granules India Lt.
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Read BioEmma Ramnarine, PhD
Executive Director, Product Management & Development Operations, Boehringer-Ingelheim
Emma Ramnarine, PhD
Boehringer-Ingelheim
Dr. Emma Ramnarine is an accomplished senior leader with 22+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Product Lifecycle Management, Outsourcing & External Collaborations, Risk Management, QC and Quality Management Systems. She was most recently Executive Director, Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio.
She is a well-recognized industry thought leader and expert on QRM and risk-based applications, providing expertise and training for regulatory authorities and the industry. She is currently Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes, an initiative sponsored by Chief Quality Officers of more than 25 global pharma companies.
Emma is currently Secretary of the PDA Board and is in the Board since 8 y. She was also on RAQAB, and has led several PDA Task Forces, Interest Group and Technical Reports (TR).
Emma holds a PhD in Pharmaceutical Sciences from TU Dublin, Ireland, an MS in Pharmaceutical Sciences from the University of Connecticut, an M Pharm and a B Pharm, both from the School of Pharmacy, SGSITS, Indore, India.
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Carmen Amelia Rodriguez Hernandez
Team Lead, Vaccines PQ, WHO
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Anshul Saxena
VP Apprenticeship, Ecosystem Development - Govt. & Industry, Life Sciences Sector Skill Development Council
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Read Bio
Vishal Sharma, MS
Co-Founder, Director, Vienni Training & Consulting LLP
Vishal Sharma, MS
Vienni Training & Consulting LLP
Masters in Microbiology (M.Sc) with over two decades of experience in working in pharmaceutical manufacturing companies & consulting. Six Sigma green belt certified by Indian Institute of Statistics. Participates in and leads the initiatives of Parenteral Drug Association India Chapter as a founding member, a chapter board member and step up as PDA India Chapter President in January 2022.
- Volunteer for PDA Journal Science & Technology as reviewer for articles on sterilization and sterility assurance.
- Member of a PDA Task force, contributing to the points to consider (PTC) for remote inspections/audits. PTC's are peer reviewed by various global regulatory agencies.
Exposure to and experience in the quality control/assurance functions in Microbiology & with exposure of facing regulatory audits, exposure to sterile manufacturing for small molecules & Sterile API, designing & validating aspects/sterilization processes for products for global market. Handled the validation laboratory establishments & functioning for filtration & validation, excels in trouble shooting, especially in the aseptic area, microbiology & sterilization using statistical approaches. Consults, trains and educates sterile parenteral manufacturing teams, engaged in operations.
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Ran Bahadur Singh
Head, Supplier Quality Audit & Compliance, South Asia, Middle East, Africa, GSK
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Gregory Smith
Country Director, US FDA, India Office
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N.S. Sreenath, PhD
CEO, Biovet
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Abhay Kumar Srivastava
President, Operations, Mankind Pharma
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Read BioDavid B. Talmage, MBA
Vice President, Education, PDA
David B. Talmage, MBA
PDA
With over 15 years in the pharmaceutical, biopharmaceutical and consumer industries, David has expertise in the quality systems leading to extensive experience in all aspects of manufacturing, validation, and inspection readiness, with a focus on process optimization and efficiency in resource utilization. His proficiencies include consent decree remediation efforts and management of quality systems, product tech transfer and rapid site growth training, pre-approval inspection readiness, commissioning and validation, and facility start-up.
David’s specializations include quality systems, sterile manufacturing, and technical training. He currently serves as the Vice President of Education for the Parenteral Drug Association (PDA) where he is responsible for the development and delivery of PDA’s training courses and the operation of the Training and Research Institute’s cleanroom and laboratories.
He has worked at Johnson & Johnson, MedImmune/AstraZeneca, Genzyme, Dendreon, and Bayer HealthCare. David holds an MBA with a concentration on operations management and a BS in chemistry from Washington State University. Go Cougs!
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Eric Twum
Regulatory Specialist, OQS, CDER, US FDA
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Krishna Venkatesh
Global Head Quality & Pharmacovigilance, Dr. Reddy's Laboratories
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Jignesh Vora
Managing Director (Partner), Accenture Strategy and Consulting
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Srivatsa Yajaman
Owner, Streamline Consulting and Analytics
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