PDA India Chapter: 2024 Annual Meeting

Hyderabad, India
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Program Highlights

Read our LinkedIn posts to get additional insights into this can't-miss event!

Elevate Your Expertise: Exceptional Learning Opportunities at the PDA Annual Meeting 2024: Maintaining Quality & Compliance in Pharmaceutical Drug Manufacturing and Regulatory Expectations. Read more here:

Event Blog 1

Ever wondered about the genesis of impurities and their journey from labs to the market? What role do processes, conditions, and transportation play? Is your risk management comprehensive enough? Learn more here:

Event Blog 2

As a result of a sold-out Annual meeting in 2023, the 2024 PDA India Chapter Annual Meeting and Workshop will continue to focus on critical topics and allow for an even broader audience. We welcome your participation to discuss topics focusing on medical devices, environmental monitoring, aseptic processing, inspectional trends on cleaning validation/cross contamination issues and findings, compliance and remediation issues.

Hear firsthand from the inspectors and compliance decision makers and ultimately those officials who inspect and review responses which affect industry for many years. Hear from Industry subject matter experts on innovative technology, data integrity, internal audits and aseptic line design in addition to other critical topics that support quality.

You will have an opportunity to select a track or session topics to participate in and share your views during interactive case studies and breakout group discussions.


Target Audience
  • Quality Assurance
  • Quality Operations
  • Regulatory Affairs
  • Research & Development
  • Marketing and Sales
  • Academia
  • Pharma Senior Level Manager
  • Executive level leaders in pharmaceutical and bio manufacturing

Questions

Registration, Exhibition and Sponsorship questions, please contact Biny Joseph.

Program questions, please contact Wanda Neal.

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EARLY REGISTRATION BY 12 JANUARY 2024COST
Conference35,000 INR (USD 420)
Workshop 30,000 INR (USD 360)

 

REGISTRATION AFTER 12 JANUARY 2024COST
Conference45,000 INR (USD 540)
Workshop35,000 INR (USD 420)

Day 1

Monday, 11 March 2024

7:00am | Registration Open

8:30am - 12:30pm | Plenary Session One (P1) - Opening Plenary Session and Keynote Presentations

Session Leaders: Rishikesh Jaiwant, Senior Director Manufacturing & Operations, Baxter India, President Elect, PDA India Chapter and Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

Session Overview: Strategic planning, concurrent monitoring, and critical evaluation of FDA initiatives will enable us to stay complaint with cGMP as well. It is important to understand regulators’ expectations. Their candid feedback and directive for new initiatives should be taken in the right spirit as their unending support for the betterment of the industry per se. Simultaneously, equal importance should be levied to comply with the basic GMP, which when violated, restricts our capacity to serve our end users – the patients. This session will bring an overarching perspective on how to maintain a state of supreme quality from regulatory perspective, and how to move the needle towards Quality Management Maturity.


8:30am - 8:45am | Welcome and Opening Remarks

  • Dr. Rustom Mody, Senior Vice President and Head R&D (Biologics), Sun Pharmaceutical Industries Ltd., and PDA President – India Chapter
  • Vishal Sharma, Immediate Past President, PDA India Chapter and Director, Vienni Training & Consulting LLP and Co-Chair, PDA India Chapter Annual Meeting
  • Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting
  • Glenn Wright, President and CEO, PDA

8:45am - 9:10am | Dr. Patrizia Cavazonni, Director, Center for Drug Evaluation and Research (CDER), US FDA

9:10am - 9:20am | Update on FDA Initiatives: Impact in India and the Region
Dr. Sarah McMullen,
Country Director, US FDA India Office

9:20am – 9:30am | Update on CDSCO Initiatives and Regulatory Compliance Expected from the Industry
Dr. Rajeev Sing Raghuvanshi,
Drug Controller General of India

9:30am - 10:00am | The Cost of Poor Quality
Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA

10:00am - 10:30am | Updates from the Office of Pharmaceutical Quality (FDA/CDER/OPQ)

  • OPQ’s Pharmaceutical Quality Initiative Updates
  • Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA

  • Office of Pharmaceutical Manufacturing Assessment (OPMA) Initiative Updates
  • Dr. Vidya Pai, Branch Chief, Office of Pharmaceutical Manufacturing Assessment, CDER/OPQ/US FDA

    10:30am - 11:00am | Updates from the Office of Pharmaceutical Quality Operations/ORA
    Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA/US FDA

    11:00am - 11:30am | Refreshment Break

    11:30am - 12:00pm | Regulatory Update: State of Quality from a Regulatory Perspective
    Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

    12:00pm - 12:30pm | Quality Culture of API Manufacturers in India – A Time Travel over 16 Years of GMP Inspections by EDQM
    Dr. Thomas Hecker, Inspector, EDQM

12:30pm - 1:30pm | Lunch and Exhibition

1:30pm - 3:30pm | Plenary Session Two (P2) - Quality Culture to Quality Maturity - What Does it Mean?

Session Leader: Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

Session Overview: Global regulators continue to focus on the importance of quality culture and its impact on the entire life cycle of pharmaceuticals. This session will illustrate how to elevate the concept of quality culture to quality maturity. The discussion will include the importance of building a reliable quality culture throughout the entire organization from technician to C-suite, how to maintain and nurture it, and how to gather and analyze metrics to understand if an organization's quality culture initiatives are working.


1:30pm - 2:00pm | Importance of having a Strong Quality Culture from C Suite to Technicians
Dr. G.K. Raju, Chairman and CEO, Light Pharma Inc.

2:00pm - 2:30pm | Quality Culture: is it Working?
Stephen Tyrpak, Associate Vice President of Operations, PQE Group

2:30pm - 3:00pm | What does True Quality Sustainability Mean?
Dr. Deva Puranam, Head, Global Quality Investigations, Surveillance & Regulatory Communications, Viatris

3:00pm - 3:30pm | Panel Discussion & Questions/Answers

  • Peter Baker, President, Live Oak Quality Assurance
  • Dr. Thomas Hecker, Inspector, EDQM
  • Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Global Compliance Branch, CDER/OMQ/US FDA
  • Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA
  • Dr. Deva Puranam, Head, Global Quality Investigations, Surveillance & Regulatory Communications, Viatris
  • Dr. G.K. Raju, Chairman and CEO, Light Pharma Inc.
  • Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA
  • Stephen Tyrpak, Associate Vice President of Operations, PQE Group

3:30pm - 4:15pm | Refreshment Break and Exhibition

4:15pm - 6:15pm | Plenary Session Three (P3) - Data Integrity: Back to the Future, An Open and Transparent DI-SIX System Approach

Session Leader: Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA

Session Overview: Data Integrity continues to be a major focus for regulatory agencies and regulated companies. This session will focus on identifying and implementing strategic controls for maintaining the integrity of the data. Get a better understanding of Data Integrity fundamentals and how they impact the Pharma industry; how to maintain your data integrity program as current through annual review; the most efficient and effective DI approaches to use as part of your DI implementation strategy; and the impact to the integrity of the data with increases in volume, sources, and complexity.


4:15pm - 4:45pm | Digitalization & Data Integrity - Lessons Learned
Alicja Wolska, Executive Director, Data and Digital Quality, Merck Sharpe & Dohme

4:45pm - 5:15pm | Current Trends on Data Integrity
Dr. Carmelo Rosa, Director, Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

5:15pm - 5:45pm | Data Integrity in 2024- How Far Have We Gone?
Peter Baker, President, Live Oak Quality Assurance

5:45pm - 6:15pm | Panel Discussion/Questions and Answers

  • Peter Baker, President, Live Oak Quality Assurance
  • Dr. Carmelo Rosa, Director, Division of Drug Quality, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting
  • Alicja Wolska, Executive Director, Data and Digital Quality, Merck Sharpe & Dohme
  • Atul Agrawal, Director, Division of Foreign Pharmaceutical Quality Inspections, ORA/OMPTO/US FDA 

Day 2

Tuesday, 12 March 2024

7:00am | Registration Open

8:00am - 10:30am | Plenary Session Four (P4) - How We Rise After a Regulatory Action

Session Leader: Rishikesh Jaiwant, Senior Director Manufacturing & Operations, Baxter India, and President Elect, PDA India Chapter

Session Overview: No company would want a regulatory action, which indicates non-compliance, and breach of regulators’ trust. Such regulatory action hurts – it impacts the capacity to serve patients, the morale of employees, and the brand image. Having said that, regulatory action is about continuous improvement and hence, instead of justifying the risks, the focus should be on accepting the challenge, being resilient to overcome the gaps, and staying committed to building a quality culture. The remediation plan should be confirmed with the agency. Considering the legalities involved, regulators should be timely updated about the progress of CAPA commitments with utmost honesty and transparency. It is all about doing what we say, and saying what we do. This session will focus on how to rebuild the trust and confidence with the agency through dedicated and committed efforts towards quality culture.


8:00am - 8:30am | Rebuilding Trust and Confidence with the Agency - Lessons Learned
Jeff Yuen, MPH, President and CEO, Jeff Yuen & Associates, Inc.

8:30am - 9:00am | Building Capabilities & Establishing GMP Compliance Sustainability
Jerry Greco, Chief Quality Officer, Baxter International

9:00am - 9:30am | How the Pharmaceutical Quality System (PQS) Enables Pharmaceutical Lifecycle Management
Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA

9:30am - 10:00am | An Examination of CAPAs Commitments and Remediation Plans
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Dr. Carmelo Rosa, Director, Division of Drug Quality I, CDER/OMQ/US FDAand Co-Chair, PDA India Chapter Annual Meeting

10:00am - 10:30am | Panel Discussion and Questions and Answers

  • Cathy Burgess, Partner, Alston & Bird, LLP 
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA/US FDA
  • Jerry Greco, Chief Quality Officer, Baxter International
  • Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
  • Dr. Thomas Hecker, Inspector, EDQM
  • Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA
  • Reem Malki, Chief Quality Officer, Sun Pharmaceutical Industries Ltd
  • Dr. Carmelo Rosa, Director, Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting
  • Jeffrey Yuen, MPH, President and CEO, Jeffrey Yuen and Associates, Inc.

10:30am - 11:00am | Refreshment Break and Exhibition

11:00am - 1:15pm | Executive Leadership Forum (P5)| The Role of Executive Leadership and Bringing the Two Worlds Together| Deep Dive into the Meaning of Quality

Session Leader: Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

Session Overview: Organizational culture influences quality outcomes and requires continuous reinforcement through senior leadership behavior and creating an ‘enabling environment’. Hear from senior leaders as they take an even deeper dive into the meaning of Quality and Culture and the overlap of Quality with Culture.


11:00am - 11:25am | How to Go Global and Meet Expectations
Sanat Chattopadhyay, Executive Vice President and President, Merck Manufacturing Division

11:25am - 11:50am | Executive Perspective on Quality
Rajiv Malik, President, Viatris

11:50am - 12:15pm | The Constructive Role that Executive Leadership Plays
Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries Ltd

12:15pm - 12:40pm | Quality Operational Perspective
M. Madan Mohan Reddy, Whole Time Director, Aurobindo

12:40pm - 1:15pm | Leadership Forum Discussion & Questions and Answers

  • Sanat Chattopadhyay, Executive Vice President and President, Merck Manufacturing Division
  • Rajiv Malik, President, Viatris
  • Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries Ltd
  • M. Madan Mohan Reddy, Whole Time Director, Aurobindo

1:15pm - 2:15pm | Lunch and Exhibition

2:15pm - 3:45pm | Concurrent Sessions

A1 | Cleaning Validation

Session Leader: Ivy Louis, PDA Board of Directors and Founder Director, Vienni Training & Consulting LLP

Session Overview: Chemistry plays a significant role in cleaning processes and could involve reactions such as saponification, oxidation-reduction, acid-base neutralization, hydrolysis or precipitation, based on the type of soil or dirt. Cleaning processes also involve a combination of physical actions (e.g., scrubbing, wiping rinsing). The confirmation of the removal depends on the agents used, the target surface or substance, the specific contaminants being addressed, and the methods of cleaning adopted. When soil or dirt is being cleaned, it either gets dislodged/breaks apart, gets dissolved, emulsified or suspended, or gets removed depending on the cleaning method and the nature of the dirt itself. There is the need to quantify this process of elimination, removal which necessitates qualification backed by validation of the cleaning process. Verification of cleaning for consistency of removal is the final aspect that provides assurance regarding the lifecycle management of cleaning. This session will discuss the regulatory expectations of the cleaning process lifecycle design to execution against the background of cases of contamination and cross contamination.


2:15pm - 2:45pm | Understanding the Compliance Risks with Cleaning Validation
Andrew D. Hopkins, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

2:45pm - 3:15pm | Inspection Trends on Cleaning Validation/Cross-Contamination Issues
Jose Melendez, Consumer Safety Officer, ORA/OMPTO/US FDA (Remote)

3:15pm - 3:45pm | Questions and Answers
Andrew D. Hopkins, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
Jose Melendez, Consumer Safety Officer, ORA/OMPTO/ US FDA (Remote)


2:15pm - 3:45pm | B1 | Process Validation

Session Leader: Brooke K. Higgins, Acting Branch Chief Senior Policy Advisor, Division of Drug Quality I, Global Compliance Branch, CDER/OMQ/US FDA

Session Overview: This session will focus on the quality and compliance requirements for an effective validation program.


2:15pm - 2:55pm | Evaluating Processes
Dr. G.K. Raju, Chairman and CEO, Light Pharma Inc.

2:55pm - 3:35pm | Knowledge Management Role in Process Validation: Guide to Sustainable Compliance
Tracy Moore, Founder and CEO, TM Pharma Group Ltd.

3:35pm - 4:00pm | Questions and Answers
Dr. Thomas Hecker, Inspector, EDQM
Tracy Moore, Founder and CEO, TM Pharma Group Ltd
Dr. G.K. Raju, Chairman and CEO, Light Pharma Inc.


4:00pm - 4:30pm | Refreshment Break and Exhibition

4:30pm - 6:30pm | Plenary Session Six (P6) - ICH Impurities

Session Leader: Dr. Sumitra Pillai, Vice President, Head of R&D, Slayback Pharma, and Treasurer, PDA India Chapter

Session Overview: Many things in life can be designed or chosen and so can be the case with impurities. Hear from industry and regulator experts who will address the important role of CGMP compliance, and the impact of drug components, supply chains, manufacturing facility competencies, ongoing testing, and other quality risk management strategies to detect, prevent, and mitigate nitrosamine impurities in drug products based on sound science for delivery of consistent quality drugs for patients. As a result of unexpected and recent findings of nitrosamine impurities in human drugs which has resulted in batch recalls or delayed marketing for some drugs, this session will discuss the current understanding of the potential root causes of nitrosamine impurities.


4:30pm - 5:00pm | Practical Application of Nitrosamine – Aurobindo Experience
Dr. Vishnubhotla Nagaprasad, President, Aurobindo

5:00pm - 5:30pm | Nitrosamines Challenges and Mitigation
Dr. Mark Mowery, Associate Vice President, Analytical Chemistry in Development and Supply, Merck & Co., Inc.

5:30pm - 6:15pm | FDA Guidance on Nitrosamine
Dr. Andre Raw, Associate Director, CDER/OPQ/OLDP/US FDA (Remote)

6:15pm - 6:30pm | Question and Answers
Dr. Vishnubhotla Nagaprasad, President, Aurobindo
Dr. Mark Mowery, Vice President, Analytical Chemistry in Development and Supply, Merck & Co., Inc. 
Dr. Andre Raw, Associate Director, CDER/OPQ/OLDP/US FDA (Remote)


6:30pm | Adjourn for Day Two

 

Day 3

Wednesday, 13 March 2024

7:00am | Registration Open

8:00am - 10:15am | Concurrent Sessions

A2 | Aseptic Operations

Session Leader: Dr. Carmelo Rosa, Director, Division of Drug Quality I, CDER/OMQ/US FDAand Co-Chair, PDA India Chapter Annual Meeting

Session Overview: Globally, one of the fundamental issues with aseptic processing of pharmaceuticals involves a local misinterpretation of standards and guidance documents which can impact the initial approval, ongoing regulatory status and efficiency of aseptic processing operations. This session will continue earlier discussions on aseptic process controls and expectations as well as provide a summary of experiences with the global interpretation of regulatory documents and misinterpretations.


8:00am - 8:30am | Aseptic Process Trends and Issues
Rick Friedman, Deputy Director for Manufacturing Quality, CDER/OMQ/US FDA (Remote)

8:30am - 8:45am | Questions and Answers

8:45am - 9:15am | Current Cases on Applications
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA

9:15am - 9:45am | How to Evaluate an Aseptic Process Operation
Thomas J. Arista, Pharmaceutical Consultant, Ventana Novo, LLC


9:45am - 10:15am | Questions and Answers
Thomas J. Arista, Pharmaceutical Consultant, Ventana Novo, LLC
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Tracy Moore, Founder and CEO, TM Pharma Group Ltd.
Jeff Yuen, MPH, President and CEO, Jeff Yuen & Associates, Inc.

8:00am - 10:15am | B2 | Unlocking Commercial Success: The Vital Role of R&D, Knowledge, and Process Transfer in Drug Manufacturing

Session Leader: Dr. Rustom Mody, Senior Vice President and Head R&D (Biologics), Sun Pharmaceutical Industries Ltd., and President, PDA India Chapter

Session Overview: During this session, hear why technology transfer is difficult and how to streamline transfers and shorten timelines, including vaccine case study transfer in India. Additionally, discover hidden and unexplored aspects of a successful technology transfer and regulatory considerations during tech transfer.


8:00am - 8:30am | Maintaining Quality and Compliance during Technology Transfer
Dr. Rajesh Kumar Singh, Associate Director, Genova Biopharmaceuticals

8:30am - 9:00am | Lessons Learned from Vaccine Tech-Transfer
Dr. Priyabrata Pattnaik, Deputy Managing Director, Indian Immunological Limited

9:00am - 9:30am | CMO Perspectives on Technology Transfer for Clinical and Commercial Stage Products
Dr. Dhananjay Patankar, Pharmaceutical Consultant

9:30am - 10:15am | Questions and Answers

10:15am - 10:45am | Refreshment Break and Exhibition

10:45am - 12:15pm | Plenary Session Seven (P7) - Combination Products

Session Leader: Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA

Session Overview: As India's life science community continues to grow, a strong focus is on combination products and their impact on traditional pharmaceutical manufacturers, especially since the court case Genus Medical Technologies vs. FDA. This session will include the regulatory and quality aspects that pharmaceutical companies need to consider when working with combination products and the importance of supplier management when developing or distributing a combination product. This session will also include case studies that illustrate how mishandling and managing combination products resulted in regulatory actions being taken.


10:45am - 11:15am | Understanding and Managing the Quality and Risk Across the Entire Combination Product Lifecycle
Stephen Tyrpak, Vice President of Operations, PQE Group

11:15am - 11:45am | Case Study on the Mishandling and Managing Combination Products Resulting in Regulatory Actions
Jose Melendez, Consumer Safety Officer, ORA/OMPTO/US FDA (Recorded)

11:45am - 12:15pm | Panel Discussion and Questions and Answers
Jose Melendez, Consumer Safety Officer, ORA/OMPTO/US FDA
Stephen Tyrpak, Vice President of Operations, PQE Group

12:30pm - 1:30pm | Lunch and Exhibition

1:30pm - 4:00pm | Plenary Session Eight (P8) - Open Mic with the Current and Former Investigators and Legal Counsel

Session Leader: Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA

Session Overview: This last session is designed to focus on key messages from current and former regulators to bring strategic and collaborative opportunities to the forefront in the discussion. Prepare your questions in advance and use this Open Mic opportunity to ask your questions and get answers.


1:30pm - 2:00pm | Update on FDA's Remote Assessment Program
Dr. Rebecca Frey Cooper, Associate Director, CDER/OMQ/US FDA

2:00pm - 2:30pm | Understanding the Legal Aspects of Information Provided to Regulators as Part of a Remediation Process | If You Said You Did it - Show It!
Cathy Burgess, Partner, Alston & Bird, LLP


2:30pm - 4:00pm | Panel Discussion: Open Mic
Atul Agrawal, Director, Division of Foreign Pharmaceutical Quality Inspections, ORA/OMPTO/OPQO/US FDA 
Thomas J. Arista, Pharmaceutical Consultant, Ventana Novo, LLC
Dr. Rebecca Frey Cooper, Associate Director, CDER/OMQ/US FDA
Dr. Thomas Hecker, Inspector, EDQM
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Global Compliance Branch, CDER/OMQ/ US FDA
Alicia Mozzachio, Consultant, Global GMP Compliance, LLC (Invited)
IIeana Barreto-Pettit, Vice President, Technical Strategic Compliance, Parexel
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting
Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA


4:00pm - 4:10pm | Closing Remarks
Dr. Rustom Mody, Senior Vice President and Head R&D (Biologics), Sun Pharmaceutical Industries Ltd. and President, PDA India Chapter

 

Day 4

Thursday, 14 March 2024

Back to Basics Workshop

Understand Key Regulatory Guidance Documents, Pharmaceutical Regulations and Published Guides, Led by Regulators and Industry Experts

The workshop is intended to have opened discussions on important guidance documents and regulations with the purpose of closing gaps and sharing the regulatory expectations that will allow industry to understand how to operate and remain in a sustainable state of control. The workshop will include practical and real case studies and encourage interaction between the participants and the regulatory and industry experts and answers to your questions.

7:00am | Registration Open

8:30am - 8:45am | Welcome
Dr. Rustom Mody, Senior Vice President and Head R&D (Biologics), Sun Pharmaceutical Industries Ltd. and President, PDA India Chapter

8:45am - 9:00am | Workshop Introduction Day One
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

9:00am - 10:00am | Why Quality Matters: Patient Perspective
Moderator: Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA

Patient Perspective:
Ms. Harita Vasireddi, Managing Director, Vimta Labs

10:00am - 10:15am | Refreshment Break

10:15am - 11:15am | Introduction to Quality: FDA Guidance Quality Systems and ICH Q10 & General Overview of OOS Specification Guidance - Examples of Inspectional Trends
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDAand Co-Chair, PDA India Chapter Annual Meeting

11:15am - 12:15pm | OOS Specification Guidance - Case Studies on Commercial and Drug Applications
Moderator: Dr. Rebecca Frey Cooper, Associate Director, CDER/OMQ/ US FDA

Case 1:
Peter Baker, President, Live Oak Quality Assurance
Atul Agrawal, Director, Division of Foreign Pharmaceutical Quality Inspections, ORA/OMPTO/OPQO/US FDA

Case 2:
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Dr. Rebecca Frey Cooper, Associate Director, CDER/OMQ/ US FDA
Ileana Barreto-Pettit, Vice President, Technical Strategic Compliance, Parexel

Pre-reading FDA Guidance Documents:

  • Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry
  • Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

12:15pm - 1:15pm | Luncheon

1:15pm - 2:00pm | Introduction to Pre-Approval Inspections
Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA

Pre-reading FDA Guidance Documents:

  • Compliance Program Guide to Pre-Approval Inspections
  • Preapproval Inspections Compliance Program
  • INTEGRATION OF FDA FACILITY EVALUATION AND INSPECTION PROGRAM FOR HUMAN DRUGS: A CONCEPT OF OPERATIONS
  • Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations

2:00pm - 2:30pm | PAI Case Study
Dr. Vidya Pai, Branch Chief, Office of Pharmaceutical Manufacturing Assessment, CDER/OPQ/US FDA

2:30pm - 3:00pm | Refreshment Break

3:00pm - 5:00pm | Introduction to Sterile Aseptic Processing | Case Studies
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Thomas J. Arista, Pharmaceutical Consultant, Ventana Novo, LLC

Question & Answer Session
Moderator: Jeff Yuen, MPH, President and CEO, Jeff Yuen & Associates, Inc.

Panelists:

Atul Agrawal, Director, Division of Foreign Pharmaceutical Quality Inspections, ORA/OMPTO/OPQO/US FDA
Thomas J. Arista, Pharmaceutical Consultant, Ventana Novo, LLC
Peter Baker, President, Live Oak Quality Assurance
Dr. Rebecca Frey Cooper, Associate Director, CDER/OMQ/ US FDA
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Tracy Moore, Founder and CEO, TM Pharma Group Ltd.
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

Pre-reading FDA Guidance Documents and EU GMP Annex 1 Revision:


  • Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry
  • Annex 1: Manufacture of Sterile Products
  • https://www.fda.gov/regulatory-information/search-fda-guidance-documents/inspection-injectable-products-visible-particulates
  • Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter | FDA

5:00pm | Adjourn for the Day

Day 5

Friday, 15 March 2024

8:30am - 10:30am | Workshop Introduction Day Two
Moderator: Ivy Louis, Board of Directors, PDA India Chapter and Founder Director Vienni Training & Consulting LLP


8:35am - 9:20am | Introduction to Data Integrity Remediation | Case Studies
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

9:20am - 10:30am | The Heart of Data Integrity
Peter Baker, President, Live Oak Quality Assurance
Atul Agrawal, Director, Division of Foreign Pharmaceutical Quality Inspections, ORA/OMPTO/OPQO/US FDA


Pre-reading FDA Guidance Documents:

  • Data Integrity and Compliance with Drug CGMP: Questions and Answers: Guidance for Industry
  • Guidance on Data Integrity (picscheme.org)
  • Guidance on GxP data integrity - GOV.UK (www.gov.uk)
  • PDA Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (single user digital version) | PDA
  • PDA Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories (single user digital version) | PDA
  • trs1033-annex4-guideline-on-data-integrity.pdf (who.int)

10:30am - 11:00am | Refreshment Break

11:00am - 4:30pm | Session Introduction: Visual Inspections
Moderator: Vikram Shukla, Vice President, PGS - Sterile Injectables & Biotech Operations, APAC Cluster, Pfizer

11:00am - 11:30pm | Visual Inspections: The Foundation with Case Studies
Stephen Tyrpak, Vice President of Operations, PQE Group


11:30am - 12:45pm | FDA Case Studies of Visual Inspection Issues
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDAand Co-Chair, PDA India Chapter Annual Meeting

Pre-reading FDA Documents:

  • Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry
  • Annex 1: Manufacture of Sterile Products
  • Inspection of Injectable Products for Visible Particulates | FDA

12:45pm - 1:45pm | Luncheon

2:00pm - 3:00pm | Visual Inspection (Hands on Demonstration)
Stephen Tyrpak, Vice President of Operations, PQE Group


3:00pm - 3:30m | Inspection, Re-inspection, Bubble and Squeak
Tracy Moore, Founder and CEO, TM Pharma Group Ltd.
Andrew D. Hopkins, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.


3:30pm - 3:45pm | Refreshment Break

3:45pm - 4:45pm | Training and It's Effectiveness
Ivy Louis, Board of Directors, PDA India Chapter and Founder Director, Vienni Training & Consulting LLP
Vishal Sharma, Immediate Past President, PDA India Chapter and Director, Vienni Training & Consulting LLP


4:45pm - 5:15pm | Question and Answer Session for Day 2
Moderator: Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting


Panelists:

Atul Agrawal, Director, Division of Foreign Pharmaceutical Quality Inspections, ORA/OMPTO/OPQO/US FDA
Peter Baker, President, Live Oak Quality Assurance
Brooke K. Higgins, Acting Branch Chief and Senior Policy Advisor, Division of Drug Quality I, Office of Compliance, CDER/OMQ/US FDA
Andrew D. Hopkins, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
Ivy Louis, Board of Directors, PDA India Chapter and Founder Director Vienni Training & Consulting LLP
Tracy Moore, Founder and CEO, TM Pharma Group Ltd.
Vishal Sharma, Immediate Past President, PDA India Chapter and Director, Vienni Training & Consulting LLP
Stephen Tyrpak, Vice President of Operations, PQE Group
Jeff Yuen, MPH, President and CEO, Jeff Yuen & Associates, Inc.

5:15pm - 5:20pm | Closing Remarks
Vishal Sharma, Immediate Past President, PDA India Chapter, and Director, Vienni Training & Consulting LLP
Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter Annual Meeting

 

 

Featured Presenters

Presenters

  • Atul J Agrawal, MS

    Supervisory Consumer Safety Officer, OPQO, ORA, U.S. FDA

    Read Bio
  • Peter E. Baker, MS

    President, Live Oak Quality Assurance

    Read Bio
  • Ileana Barreto-Pettit

    Vice President, Technical Strategic Compliance, Parexel

    Read Bio
  • Cathy L. Burgess

    Partner, Alston & Bird, LLP

    Read Bio
  • Sanat Chattopadhyay

    Executive Vice President and President, Merck Manufacturing Division

    Read Bio
  • Alonza E. Cruse

    Director, OPQO, ORA, U.S. FDA

    Read Bio
  • Dr. Rebecca Frey-Cooper

    Associate Director, CDER/OMQ/US FDA

    Read Bio
  • Rick L. Friedman, MS

    Deputy Director for Manufacturing Quality, CDER/OMQ/US FDA

    Read Bio
  • Jerry Greco

    Chief Quality Officer, Baxter International

    Read Bio
  • Dr. Thomas Hecker

    Inspector, EDQM

    Read Bio
  • Brooke K. Higgins, MS

    Acting Branch Chief and Senior Policy Advisor, Div. of Drug Quality I, CDER/OMQ/US FDA

    Read Bio
  • Andrew D. Hopkins

    Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    Read Bio
  • Rishikesh Jaiwant

    Senior Director Manufacturing & Operations, Baxter India

    Read Bio
  • Ivy Louis, M.Pharm MBA(HRM)

    Founder, Director, Vienni Training & Consulting LLP

    Read Bio
  • Dr. Rustom Mody

    Senior Vice President and Head R&D (Biologics), Sun Pharma Ltd.

    Read Bio
  • Tracy Moore

    Founder & CEO, TM Pharma Group Ltd

    Read Bio
  • Dr. Mark Mowery

    Associate Vice President, Merck & Co., Inc.

    Read Bio
  • Dr. Vishnubhotla Nagaprasad

    Chief Scientific Officer, Formulations R&D, Aurobindo Pharma limited

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  • Dr. Dhananjay Patankar

    Pharmaceutical Consultant

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  • Priyabrata Pattnaik

    Deputy Managing Director, Indian Immunologicals Limited

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  • Dr. Erika Pfeiler

    Branch Chief, Division of Microbiology, CDER/US FDA

    Read Bio
  • Dr. Sumitra Pillai

    Vice President and Head R&D, Slayback Pharma, India

    Read Bio
  • Dr. Deva H. Puranam

    Head-Global Quality Investigations, Surveillance & Regulatory Communications, Viatris

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  • Mahesh R. Ramanadham, PharmD, MBA

    Deputy Director, CDER/OPQ/US FDA

    Read Bio
  • M. Madan Mohan Reddy

    Whole Time Director, Aurobindo Pharma Limited

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  • Dr. Carmelo Rosa

    Director, Division of Drug Quality I, CDER/OMQ/US FDA

    Read Bio
  • Dr. Anil Sawant

    Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA

    Read Bio
  • Vishal Sharma, MS

    Director, Vienni Training & Consulting LLP

    Read Bio
  • Vikram Shukla

    Vice President - Sterile Injectable and Biotech Operations – APAC Cluster, Pfizer

    Read Bio
  • Stephen Tyrpak

    Associate VP of Operations; US & Canada, and Associate Partner with PQE Group

    Read Bio
  • Jeff Yuen, MPH

    President and CEO, Jeff Yuen & Associates, Inc.

    Read Bio

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.

Novotel Hyderabad Convention Centre, Hyderabad


Novotel Hyderabad Convention Centre

Check in: 2 PM
Check-out : 12 PM

Hotel Reservations and Rates

  1. Step 1: Click on the "Make a Reservation" tab located under the Travel section. This action will redirect you to the Novotel Convention Centre page, where you can securely book your room for the PDA India Chapter Annual Meeting.
  2. Step 2: Enter the desired check-in and check-out dates accurately.
  3. Select your preferred room type and proceed with the reservation process
  4. Cancellation for full refund required 72 hours prior to check-in.

**PLEASE READ** PDA India Chapter is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA India Chapter or the PDA India Chapter chosen hotel contacts you suggesting that they represent any PDA India Chapter event, they do not. It is PDA India Chapter’s recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


Novotel Hyderabad Convention Centre, a tranquil oasis next to HITEC City, the IT hub of Hyderabad. With 15 acres of sprawling landscaped gardens around a 287-room property, guests can leave the city behind for a while and enjoy a revitalizing break surrounded by lush greenery in a serene setting.

  • 287 room
  • Spa
  • Salon
  • 24-hour fitness centre
  • Outdoor swimming pool
  • Restaurants & bars
  • Premium Lounge
How to Get Here
By Air The airport closest to Novotel Hyderabad Convention Centre is Rajiv Gandhi International Airport
By Car Novotel & HICC Complex, (Near HITEC City), P.O. Bag 1101, Cyberabad Post Office, HYDERABAD - 500 081, INDIA. On-site parking is available