PDA India Chapter: 2024 Annual Meeting
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
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.
Registration
Download Registration FormProgram 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 1Ever 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 2Highlighted Presenters
Key Presenters
-
-
-
-
-
-
Brooke K. Higgins, MS
CDER/OMQ/US FDA
Acting Branch Chief and Senior Policy Advisor, Div. of Drug Quality I
Read Bio -
Rajiv Malik
Viatris
President
-
-
-
-
Dilip Shanghvi
Sun Pharmaceuticals Industry Ltd
Managing Director
Agenda
Discover What's Happening Each Day
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
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 9:20am – 9:30am | Update on CDSCO Initiatives and Regulatory Compliance Expected from the Industry 9:30am - 10:00am | The Cost of Poor Quality 10:00am - 10:30am | Updates from the Office of Pharmaceutical Quality (FDA/CDER/OPQ)
Mahesh Ramanadham, Pharm.D, Deputy Director, CDER/OPQ/US FDA 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 11:00am - 11:30am | Refreshment Break 11:30am - 12:00pm | Regulatory Update: State of Quality from a Regulatory Perspective 12:00pm - 12:30pm | Quality Culture of API Manufacturers in India – A Time Travel over 16 Years of GMP Inspections by 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 2:00pm - 2:30pm | Quality Culture: is it Working? 2:30pm - 3:00pm | What does True Quality Sustainability Mean? 3:00pm - 3:30pm | Panel Discussion & Questions/Answers
|
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 4:45pm - 5:15pm | Current Trends on Data Integrity 5:15pm - 5:45pm | Data Integrity in 2024- How Far Have We Gone? 5:45pm - 6:15pm | Panel Discussion/Questions and Answers
|
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 8:30am - 9:00am | Building Capabilities & Establishing GMP Compliance Sustainability 9:00am - 9:30am | How the Pharmaceutical Quality System (PQS) Enables Pharmaceutical Lifecycle Management 9:30am - 10:00am | An Examination of CAPAs Commitments and Remediation Plans 10:00am - 10:30am | Panel Discussion and Questions and Answers
|
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 11:25am - 11:50am | Executive Perspective on Quality 11:50am - 12:15pm | The Constructive Role that Executive Leadership Plays 12:15pm - 12:40pm | Quality Operational Perspective 12:40pm - 1:15pm | Leadership Forum Discussion & Questions and Answers
|
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 2:45pm - 3:15pm | Inspection Trends on Cleaning Validation/Cross-Contamination Issues 3:15pm - 3:45pm | Questions and Answers |
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 2:55pm - 3:35pm | Knowledge Management Role in Process Validation: Guide to Sustainable Compliance 3:35pm - 4:00pm | Questions and Answers |
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
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 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! |
2:30pm - 4:00pm | Panel Discussion: Open Mic |
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
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
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
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.
Novotel Hyderabad Convention Centre, Hyderabad
Novotel Hyderabad Convention Centre
Check in: 2 PM
Check-out : 12 PM
Hotel Reservations and Rates
- 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.
- Step 2: Enter the desired check-in and check-out dates accurately.
- Select your preferred room type and proceed with the reservation process
- 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
Registration
Pricing Options
| EARLY REGISTRATION BY 12 JANUARY 2024 | COST |
|---|---|
| Conference | 35,000 INR (USD 420) |
| Workshop | 30,000 INR (USD 360) |
| REGISTRATION AFTER 12 JANUARY 2024 | COST |
|---|---|
| Conference | 45,000 INR (USD 540) |
| Workshop | 35,000 INR (USD 420) |
Presenters
Meet the Experts
-
-
-
-
-
-
-
-
-
-
-
Brooke K. Higgins, MS
CDER/OMQ/US FDA
Acting Branch Chief and Senior Policy Advisor, Div. of Drug Quality I
Read Bio -
-
-
-
-
-
-
Dr. Vishnubhotla Nagaprasad
Aurobindo Pharma limited
Chief Scientific Officer, Formulations R&D
Read Bio -
-
-
-
-
Dr. Deva H. Puranam
Viatris
Head-Global Quality Investigations, Surveillance & Regulatory Communications
Read Bio -
-
-
-
-
-
Vikram Shukla
Pfizer
Vice President - Sterile Injectable and Biotech Operations – APAC Cluster
Read Bio -
Stephen Tyrpak
Associate VP of Operations; US & Canada, and Associate Partner with PQE Group
Read Bio -
Sponsors
Sponsors and Collaborators
Exhibitors
Exhibitors and Innovators
Attendee List Email Scam
Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA's conferences and events. These emails are sent by scammers.
Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.
Become a Sponsor and/or Exhibitor
Amplify Your Presence and Reach Your Customers!
Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the PDA India Chapter: 2024 Annual Meeting! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
Request InformationBecome an Exhibitor
Boost your brand and visibility by becoming an exhibitor at the PDA India Chapter: 2024 Annual Meeting! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
Request InformationHave a question or need assistance?
Send us a message, and our team will get back to you shortly. We're here to help!