PDA India Chapter: 2024 Annual Meeting

Featured Presenters

• 

  Sanat Chattopadhyay

  Executive Vice President and President, Merck Manufacturing Division

  Read Bio

  

  Sanat Chattopadhyay

  Merck Manufacturing Division

  Sanat Chattopadhyay is executive vice president and president, Merck Manufacturing Division. He has responsibility for the company’s worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. A proven leader in the biopharmaceutical industry, Sanat joined Merck in November 2009 as senior vice president of global vaccines and sterile manufacturing operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its vaccine business. Under Sanat’s leadership, Merck is currently executing significant expansion of its biologics and vaccines manufacturing capacity to reach more patients around the globe.

  Before joining Merck, he served as senior vice president, technical operations and product supply, for Wyeth Pharmaceuticals, with responsibility for product supply, process development and operational excellence. Previously, he worked at Aventis and its predecessor companies as senior vice president, industrial operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific.A graduate chemical engineer from Jadavpur University and post-graduate industrial engineer from NITIE, India, Sanat is widely travelled, having lived with his family in five countries across three continents.
• 

  Alonza E. Cruse

  Director, Office Pharmaceutical Quality Operations, ORA, U.S. FDA

  Read Bio

  

  Alonza E. Cruse

  U.S. FDA

  Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative. From 2013 – 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments, and on the development of a new inspection protocols program. Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in medical technology from York College (City University of New York).
• 

  Rick L Friedman, MS

  Deputy Director, OMQ, OC, CDER, U.S. FDA

  Read Bio

  

  Rick L Friedman, MS

  U.S. FDA

  Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability and promoting sound CGMP compliance policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University and his M.S. in Microbiology from Georgetown University School of Medicine.
• 

  Jerry Greco

  Chief Quality Officer, Baxter International

  Read Bio

  

  Jerry Greco

  Baxter International

  Jerry is a highly regarded executive with extensive leadership experience spanning quality roles across five major global healthcare companies. He most recently served as the Global Quality Officer at Takeda Pharmaceuticals, where he led all quality and quality compliance functions for the company. Prior to Takeda, he served in roles of increasing responsibility at Teva Pharmaceuticals, Pfizer and Wyeth Pharmaceuticals; he started his career at Johnson & Johnson. Jerry earned his bachelor’s degree in biological sciences from Rutgers University, his master’s in microbiology from University of Medicine and Dentistry of New Jersey, and his Ph.D. in microbiology and molecular genetics from Rutgers University.
• 

  Dr. Thomas Hecker

  Inspector, EDQM

  Read Bio

  

  Dr. Thomas Hecker

  EDQM

  Thomas Hecker is licensed pharmacist since 1994. He post graduated as specialised pharmacist in Toxicology and Environmental Protection in 1998. He also holds a PhD in Pharmaceutical Chemistry. From 2002 to 2007 he worked as GMP/GCP Inspector in Federal State of Thuringia/Germany. In 2007 he joined the Certification of Substances Department of  EDQM where he is currently working as GMP inspector. He represents EDQM at various bodies, such as the Inspectors Working Group that is hosted by the European Medicines Agency.

• 

  Brooke K. Higgins, MS

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

  Read Bio

  

  Brooke K. Higgins, MS

  CDER/OMQ/US FDA

  Brooke K. Higgins is an Acting Branch Chief and Senior Policy Advisor for the Division of Drug Quality I, Office of Manufacturing Quality, with in CDER’s Office of Compliance. In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, Ms. Higgins continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

• 

  Rajiv Malik

  President, Viatris

• 

  M. Madan Mohan Reddy

  Whole Time Director, Aurobindo Pharma Limited

  Read Bio

  

  M. Madan Mohan Reddy

  Aurobindo Pharma Limited

  M. Madan Mohan Reddy has a Master’s Degree in Science (Organic Chemistry) and held top managerial positions in leading pharma companies. He brings valuable experience in regulatory affairs of the pharma industry. Prior to joining the Company,  he was working as the Managing Director of M/s. Srichakra Remedies Limited.
• 

  Dr. Carmelo Rosa

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

  Read Bio

  

  Dr. Carmelo Rosa

  CDER/OMQ/US FDA

  Carmelo Rosa, Psy.D, Director Division of Drug Quality I - holds a BS/MS, and a doctoral degree as a Clinical Psychologist.  He has been with the FDA for 33 years. In1990, he started as an Investigator for the Los Angeles DO. Worked for approx. 18 years as a drug Investigator, CO and member of the foreign drug inspection cadre. He conducted complex drug inspections and many criminal investigations that resulted in significant actions (e.g., WLs, Seizures, IA, CD, Prosections & Injunctions). In 2008 he transferred to the DC area. He served as a CO, TL, BC and is the Director for the Division Drug Quality I. Dr. Rosa is the former Chair of the PIC/S API Expert Circle and Professor Federal Laws enforced by FDA. He has served as a US Gov. GMP Expert Witness and CGMP trainer. He works very closely with International Regulatory Authorities. He is a frequent speaker in domestic and international conferences. Dr. Rosa is responsible for the review of inspection reports related to drug manufacturing facilities that may result in a regulatory action. On his free time he is a bass/guitar player, serves as a Licensed Psychologist, and enjoys cooking and being with his family.

• 

  Dr. Anil Sawant

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

  Read Bio

  

  Dr. Anil Sawant

  Merck Sharpe & Dohme, USA

  Dr. Anil Sawant has more than 30 years of experience in the pharmaceutical industry in Quality & Compliance, Pharmaceutical Microbiology, Business Ethics, Auditing, and R&D functions.  He has worked on various dosage forms, and various product types, drugs, biologics, vaccines, medical devices, and consumer products.  He was of the teams that launched the first antibody-drug conjugate product and first photoactive drug in the US.   Currently, Anil is Sr. Vice President, Global Quality Transformation, Merck Sharpe & Dohme. He is currently focused on digital transformation of GMP systems supporting supply chains to increase global patient access.  Prior to joining MSD, Anil served in senior executive roles at Johnson & Johnson and at Pfizer. Anil has been a PDA Member and volunteer since 1992.  and is currently the Chair-Elect, PDA Board of Directors.   He is co-authored numerous PDA Technical Reports and position papers and lead the Data Integrity and COVID-19 Task Force. He has also published numerous scientific papers in infectious diseases, antimicrobials, and yeast physiology. Anil holds a B.Sc. Honors and a M.Sc. Honors in Microbiology & Biochemistry from Panjab University, India, and a PhD in Microbial and Biochemical Sciences from Georgia State University, Atlanta. He is recipient of the GSU Distinguished Alumni Achievement Award. Anil serves on the Board of the non-profit Mind Your Brain Foundation and has served on the Board of Directors of GSU Alumni Association.

• 

  Dilip Shanghvi

  Managing Director, Sun Pharmaceuticals Industry Ltd

Presenters

• 

  Atul J Agrawal, MS

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

  Read Bio
  

  Atul J Agrawal, MS

  U.S. FDA

  Atul J. Agrawal is currently a Branch Chief in FDA’s Office of Regulatory Affairs (ORA) in the Division of Foreign Pharmaceutical Quality Inspections. Prior to his current position, Mr. Agrawal served as a Consumer Safety Officer and Supervisory Consumer Safety Officer in ORA and FDA’s India Office. Mr. Agrawal began his career in the FDA as a pharmaceutical investigator in FDA’s Baltimore and New Jersey Districts, wherein he conducted domestic and foreign pharmaceutical inspections. In addition to his current role in ORA’s foreign pharmaceutical inspections, Mr. Agrawal is also involved in several PIC/S initiatives, including the PIC/S Working Group on Data Integrity, the PIC/S International Active Pharmaceutical Ingredient Inspection Programme and the PIC/S International Inspection Pilot Programme covering Manufacturers of Sterile Medicinal Products. Mr. Agrawal has and continues to teach at various pharmaceutical training courses for ORA Field Investigators and FDA Centers. Mr. Agrawal has a master’s degree in Molecular Biology from Long Island University in New York.
• 

  Peter E. Baker, MS

  President, Live Oak Quality Assurance

  Read Bio
  

  Peter E. Baker, MS

  Live Oak Quality Assurance

  Peter E. Baker, President - Live Oak Quality Assurance, is a consultant specializing in Data Governance and Quality Risk Management. He spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA.
• 

  Ileana Barreto-Pettit

  Vice President, Technical Strategic Compliance, Parexel

  Read Bio
  

  Ileana Barreto-Pettit

  Parexel

  During her 24-year tenure at the U.S. Food and Drug Administration, Ms. Barreto-Pettit has held various roles, including her most recent position as Drug National Expert within the Office of Regulatory Affairs (ORA). She is considered a Subject Matter Expert (SME) in the FDA’s inspectional process, GMP regulations and expectations, and compliance programs and policies.  Throughout her career, she has conducted hundreds of domestic and international inspections of sterile and non-sterile drug manufacturers where she identified significant GMP deficiencies resulting in compliance actions. These actions have included the immediate cessation of production operations, the issuance of Warning Letters and Import Alerts, as well as injunctions, seizures, destructions, and recalls of adulterated drug products. Barreto-Pettit has extensive knowledge and understanding of Good Manufacturing Practice (GMP) regulations and their applicability to sterile and non-sterile drug manufacturing processes.  She has served as a Senior Trainer in the FDA Drug School for 17 years. In this role, she has trained hundreds of new drug investigators, compliance officers, chemists, microbiologists, and drug application reviewers on 21 CFR 211 regulations and the ORA inspectional process. Furthermore, Ms. Barreto-Pettit has represented the FDA as an SME in various agency, national, and international groups and organizations. She has also played an instrumental role in the revision of international inspectional documents which are utilized by GMP regulators from multiple countries. Barreto-Pettit is currently a VP-Technical with Parexel International where she is utilizing her FDA investigational experience to assist drug manufacturing companies in preparing for FDA inspections and implement effective corrective and preventive actions. Her goal is to assist companies in achieving sustainable GMP compliance to ensure drug products are safe and effective, and drug shortages are prevented.

• 

  Cathy L. Burgess

  Partner, Alston & Bird, LLP

  Read Bio
  

  Cathy L. Burgess

  Alston & Bird, LLP

  Cathy Burgess is a distinguished professional with over 30 years of expertise in guiding FDA-regulated entities toward achieving business objectives while mitigating compliance and enforcement risks. As the leader of the FDA Compliance and Enforcement Team at Alston & Bird, Cathy provides strategic counsel to clients, specializing in CGMP regulation and product risk management.In her role, Cathy collaborates with clients to identify and address potential risks throughout the product life cycle. Her extensive experience encompasses prescription and OTC drugs, biologics, medical devices, foods, cosmetics, and current good manufacturing practice (CGMP) regulation.As a Partner, Cathy has a proven track record of advising on a spectrum of matters, including liability risk assessments, quality system remediation, inspection management, recalls, and responses to Form FDA 483s and warning letters. She is recognized as a leading practitioner for life sciences, ranked in The Best Lawyers in America© in FDA and Food and Beverage Law, and holds a prominent position in Chambers USA in Pharmaceutical/Medical Products Regulatory.Cathy's role at Alston & Bird follows her tenure as Associate General Counsel for the American Red Cross, where she oversaw regulatory matters. She has a history of successful negotiations, including resolving import alerts, warning letters, and FDA consent decrees. Her expertise extends to pandemic-related counseling, regulatory due diligence, and providing guidance on compliance obligations surrounding the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).Cathy is a thought leader in the industry, as evidenced by her numerous publications and presentations on topics such as CGMPs, data integrity, and FDA compliance. She has received recognition for her contributions, including the FDLI 2023 Distinguished Service and Leadership Award.Cathy Burgess is a member of the Food and Drug Law Institute's board of directors and has chaired various committees, demonstrating her commitment to professional and community engagement. She is admitted to practice in the District of Columbia and holds a Juris Doctor from The Catholic University of America.For unparalleled expertise in navigating FDA regulations and ensuring compliance, Cathy Burgess stands out as a trusted and accomplished partner in the pharmaceutical and life sciences industries.
• 

  Sanat Chattopadhyay

  Executive Vice President and President, Merck Manufacturing Division

  Read Bio
  

  Sanat Chattopadhyay

  Merck Manufacturing Division

  Sanat Chattopadhyay is executive vice president and president, Merck Manufacturing Division. He has responsibility for the company’s worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. A proven leader in the biopharmaceutical industry, Sanat joined Merck in November 2009 as senior vice president of global vaccines and sterile manufacturing operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its vaccine business. Under Sanat’s leadership, Merck is currently executing significant expansion of its biologics and vaccines manufacturing capacity to reach more patients around the globe.

  Before joining Merck, he served as senior vice president, technical operations and product supply, for Wyeth Pharmaceuticals, with responsibility for product supply, process development and operational excellence. Previously, he worked at Aventis and its predecessor companies as senior vice president, industrial operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific.A graduate chemical engineer from Jadavpur University and post-graduate industrial engineer from NITIE, India, Sanat is widely travelled, having lived with his family in five countries across three continents.
• 

  Alonza E. Cruse

  Director, Office Pharmaceutical Quality Operations, ORA, U.S. FDA

  Read Bio
  

  Alonza E. Cruse

  U.S. FDA

  Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative. From 2013 – 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments, and on the development of a new inspection protocols program. Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in medical technology from York College (City University of New York).
• 

  Dr. Rebecca Frey-Cooper

  Associate Director, CDER/OMQ/US FDA

  Read Bio
  

  Dr. Rebecca Frey-Cooper

  CDER/OMQ/US FDA

  Rebecca Frey-Cooper is the Associate Director for Regulatory Programs in the FDA Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Manufacturing Quality. In this role she provides oversight and direction for the  review of drug manufacturing quality issues, regulatory action recommendations regarding inspections, and development and implementation of compliance policies. Rebecca Frey-Cooper received her undergraduate degree from King’s College in 2005 and worked as a laboratory assistant at a nitroglycerine API manufacturer.  She obtained her PhD from the University of South Carolina in analytical and organic chemistry techniques focusing on chemical processes that govern the natural attenuation of microbial signals.  She subsequently worked for the API manufacturer, Noramco (a Johnson & Johnson subsidiary), as a post-doctoral fellow and senior scientist within the laboratory and production with emphasis in method validation, technical transfers, and new product introduction. In 2013, she joined the FDA and has served in various functions within CDER’s Office of Compliance. She is currently overseeing regulatory and enforcement programs for both foreign and domestic Current Good Manufacturing Practice (CGMP) cases.
• 

  Rick L. Friedman, MS

  Deputy Director for Manufacturing Quality, U.S. FDA

  Read Bio
  

  Rick L. Friedman, MS

  U.S. FDA

  Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability and promoting sound CGMP compliance policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his BS in Biology with honors from Montclair State University and his M.S. in Microbiology from Georgetown University School of Medicine.

• 

  Jerry Greco

  Chief Quality Officer, Baxter International

  Read Bio
  

  Jerry Greco

  Baxter International

  Jerry is a highly regarded executive with extensive leadership experience spanning quality roles across five major global healthcare companies. He most recently served as the Global Quality Officer at Takeda Pharmaceuticals, where he led all quality and quality compliance functions for the company. Prior to Takeda, he served in roles of increasing responsibility at Teva Pharmaceuticals, Pfizer and Wyeth Pharmaceuticals; he started his career at Johnson & Johnson. Jerry earned his bachelor’s degree in biological sciences from Rutgers University, his master’s in microbiology from University of Medicine and Dentistry of New Jersey, and his Ph.D. in microbiology and molecular genetics from Rutgers University.
• 

  Dr. Thomas Hecker

  Inspector, EDQM

  Read Bio
  

  Dr. Thomas Hecker

  EDQM

  Thomas Hecker is licensed pharmacist since 1994. He post graduated as specialised pharmacist in Toxicology and Environmental Protection in 1998. He also holds a PhD in Pharmaceutical Chemistry. From 2002 to 2007 he worked as GMP/GCP Inspector in Federal State of Thuringia/Germany. In 2007 he joined the Certification of Substances Department of  EDQM where he is currently working as GMP inspector. He represents EDQM at various bodies, such as the Inspectors Working Group that is hosted by the European Medicines Agency.

• 

  Brooke K. Higgins, MS

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

  Read Bio
  

  Brooke K. Higgins, MS

  CDER/OMQ/US FDA

  Brooke K. Higgins is an Acting Branch Chief and Senior Policy Advisor for the Division of Drug Quality I, Office of Manufacturing Quality, with in CDER’s Office of Compliance. In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, Ms. Higgins continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

• 

  Andrew D Hopkins, PGDip

  Director, Operation Quality QA Audit and Compliance, AbbVie

  Read Bio
  

  Andrew D Hopkins, PGDip

  AbbVie

  Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 40 years Currently Andrew is a Director of Compliance at Abbvie with responsiblity for Microbiological contamination the role includes developing long term financial strategy for site investment, assessment of manufacturing sites andTraining and mentoring. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in several areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companies) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chaired the working group for the revision of Annex 1 • Supporting industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Before joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.
• 

  Rishikesh Jaiwant

  Senior Director Manufacturing & Operations, Baxter India

  Read Bio
  

  Rishikesh Jaiwant

  Baxter India

  Rishikesh Jaiwant is the Plant Manager, Occupier, Board of Director of Baxter Pharmaceuticals India, Ahmedabad since January 2019 and responsible for delivering manufactured products and inter-plant services that meet safety, quality, cost and on-time delivery goals in support of associated business objectives. Mr. Jaiwant joined Baxter from GlaxoSmithKline plc (GSK) and has over two decades of experience in pharmaceutical and vaccines manufacturing in FDA regulated facilities. His most recent position was Site Director at the Ankleshwar (India) Vaccine Plant. He has global experience with GSK which includes 4 years at the Marietta (PA), USA vaccine manufacturing site. His experience includes working in Operations, Quality, Project Management, Operational Excellence & Technical Trainings. Rishikesh holds a post graduate in Pharmaceutical Chemistry from, Indore, India. He enjoys meeting & interacting with people, watching movies & spending time with daughters.

• 

  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. 

• 

  Dr. Rustom Mody

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

  Read Bio
  

  Dr. Rustom Mody

  Sun Pharma Ltd.

  A biotechnologist having experience of directing Biopharmaceutical programs for 4 multinational biopharmaceutical companies spanning over two decades. Dr. Mody has grown up the value chain by living through the experience of developing Biologicals, which includes vaccines, biosimilars and novel biologics. In this journey, he has gained valuable experience of creating the entire value chain for a vaccine and 6 biosimilar programs from concept to their commercialization in India and the rest-of-world markets; 3 of which were ‘first-to-market’. He has also contributed to 2 review articles, 2 book chapters, 33 publications in peer-reviewed journals and 24 filed patents and 8 granted patents.

• 

  Tracy Moore

  Founder & CEO, TM Pharma Group Ltd

  Read Bio
  

  Tracy Moore

  TM Pharma Group Ltd

  In her capacity as an Expert GMDP Inspector, Tracy played a pivotal role as the primary MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain. Her expertise extended to providing guidance on the regulation of QP certification and overseeing the deployment of vaccines under Regulation 174. Tracy also contributed significantly to the pharmaceutical landscape by supporting the drafting of the GMP Annex 1 update, actively sharing insights on this matter at global events such as PIC/S. Among her notable achievements, Tracy served as the MHRA Data Integrity GXP lead and assumed the role of MHRA FMD GMP lead. Her involvement extended to being a key member of drafting groups for EU GMP Annex 16, Annex 21, Annex 1, Chapter 4, and Annex 11. Tracy represented MHRA on PIC/S subcommittees and took on leadership responsibilities by chairing working groups. Before joining the MHRA Inspectorate, Tracy amassed 22 years of experience in the pharmaceutical and Bio-Pharmaceutical industry. Her diverse roles encompassed QA, QP, and management positions in both commercial and R&D environments, covering a range of sterile and non-sterile product dosage forms. Tracy's responsibilities included conducting audits and overseeing Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers. With a decade of experience as a GMP Inspector and an additional three years as an Expert GMDP Inspector, Tracy has demonstrated a commitment to ensuring regulatory compliance and fostering collaboration with European and international regulatory authorities. Her multifaceted contributions extend to shaping and refining industry standards, making her a respected figure in the pharmaceutical regulatory landscape.

• 

  Dr. Mark Mowery

  Associate Vice President, Merck & Co., Inc.

  Read Bio
  

  Dr. Mark Mowery

  Merck & Co., Inc.

  Dr. Mark Mowery is currently Associate Vice President at Merck and Co., Inc., leading the Analytical Chemistry organization supporting new product commercialization and in-line product support. In this role he leads the global organization responsible for late phase analytical development, launch, and life-cycle management for small molecule drug substance and products.  Mark received his PhD in chemistry from the University of Michigan in Ann Arbor, MI. Mark has extensive experience in all phases of pharmaceutical development and commercial product lifecycle management through direct experience in both the Research and Manufacturing Divisions at Merck where he has had leadership roles in the development, regulatory filing, and commercialization of numerous products. Mark has published numerous research and review articles covering a wide range of topics in chemistry and pharmaceutical research and development. Has also been active in industry forums and scientific organizations including PhRMA, the American Association of Pharmaceutical Scientists, the American Chemical Society, and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ).

• 

  Dr. Vishnubhotla Nagaprasad

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

  Read Bio
  

  Dr. Vishnubhotla Nagaprasad

  Aurobindo Pharma limited

  Mr. Vishnubhotla Nagaprasad is working as a Chief Scientific Officer, Formulations R&D at Aurobindo Pharma limited, Hyderabad. He has completed postgraduate in Pharmacy from Banaras Hindu University, Varanasi. He is having more than 30 years of experience in formulation R&D at different positions. He worked earlier with reputed Pharma companies like Cipla, Dr.Reddy’s labs and Ranbaxy. He led the development of innovative dosage form to resolve the challenges of solubility, stability and bio-availability of the drug molecules. He introduced many novel technologies in the development of new products. His current responsibilities include drug product development life cycle management including assessment of new products, formulation development, dossier filing and facilitating commercialisation of various dosage forms like oral and non-oral dosage forms for various global markets. He led vision and policy guidelines by providing a strategic guidance to ensure business goals are met and he also has more than 50 patents to his name. He is one of the leading researcher in the global generic market in Indian pharmaceutical industry.
• 

  Dr. Dhananjay Patankar

  Pharmaceutical Consultant

  Read Bio
  

  Dr. Dhananjay Patankar

  Dr. Dhananjay Patankar is an independent biopharmaceutical professional and has been intimately involved in the growth of the Indian biopharmaceutical industry since its early days.

  Over his career, he led teams that developed India’s first biosimilar therapeutic product, India’s first biosimilar approved for marketing in Europe, India’s first EU-GMP certified biologics manufacturing facility, and India’s first commercial contract manufacturing of a novel biologic for the US market.  He has served in various national committees and biotechnology industry bodies in India, and was Biologics Expert Committee member at the US Pharmacopeia from 2011 till 2020.

  By education he is a Chemical Engineer with bachelor’s degree from IIT Mumbai and Ph.D. from University of Utah in the US.

• 

  Priyabrata Pattnaik

  Deputy Managing Director, Indian Immunologicals Limited

  Read Bio
  

  Priyabrata Pattnaik

  Indian Immunologicals Limited

  Priyabrata Pattnaik got over 23 years of experience in dealing with vaccine research & development, management of biologics operations, global vaccine program, applications support, process engineering, and business development. He conceptualized, strategized, and managed cross functional teams that led to the development and commercialization of several vaccines, biologics, and diagnostics. Currently, in addition to actively serving as Board Member of Indian Immunologicals, his position as Deputy Managing Director - entails management of technical operations within the company.
• 

  Dr. Erika Pfeiler

  Branch Chief, Division of Microbiology, CDER/US FDA

  Read Bio
  

  Dr. Erika Pfeiler

  CDER/US FDA

  Dr. Erika Pfeiler is a microbiologist and Branch Chief in the FDA/CDER Division of Microbiology Assessment, where she performs and oversees microbiology reviews of ANDAs, NDAs, and INDs.  She joined CDER in 2012.  Her areas of particular interest in pharmaceutical microbiology include rapid microbiological testing methods, pharmacy compounding, and the microbiological aspects of nonsterile products. Dr. Erika Pfeiler has an educational background in food microbiology, and received a B.S. from the University of Tennessee and a Ph.D. from North Carolina State University.  

• 

  Dr. Sumitra Pillai

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

  Read Bio
  

  Dr. Sumitra Pillai

  Slayback Pharma, India

  Dr. Sumitra Pillai is a pharmaceutical professional with around two decades of industrial experience. Currently she is Vice President- Head R & D at Slayback Pharma, India. Dr. Pillai has also worked with other Indian Pharmaceutical giants such as Aurobindo Pharma, Zydus Cadila Healthcare Ltd, Intas Pharma and Dr. Reddy’s Laboratories. Her experience includes development, scale-up and successful approval of Parenteral and Ophthalmic products globally with core focus on leading geographies like North America and Europe.  Dr. Pillai holds a doctorate in Pharmaceutical Sciences.

• 

  Dr. Deva H. Puranam

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

  Read Bio
  

  Dr. Deva H. Puranam

  Viatris

  Deva H. Puranam is the Head of Global Quality Investigations, Surveillance and Regulatory communications at Viatris, a global healthcare company. Deva is a graduate of Andhra University in India, where he received his master’s degree in Analytical Chemistry of Drugs, and he is currently pursuing his doctorate degree in pharmaceutical analytical chemistry. Deva also holds a master’s degree in management studies from University of Madras in India. Throughout his 24 years of professional career, Deva worked for various global pharma companies (Eli Lily, Ranbaxy, Thermo Fisher, Baxter, Mylan) in leadership positions with increasing responsibilities. He led one of the largest clinical trials for U.S. Army Medical Research and Materiel Command Sponsored project for Traumatic Brain Injury for deployed U.S. forces in combat zones, directly monitored by Vice Chief of Staff of the United States Army, that reported into congressional committees on military health. Deva also served as US Observer with NATO - OTAN Research Technology Organization. During his professional career, he successfully conducted due diligences worth $21Bn from quality and compliance perspective. Deva participates in industry forums of ISPE, DIA, PDA and actively partners with regulators and special interest groups on key pharmaceutical topics such as compliance, quality, risk and continuous improvement. Deva passionately believes in Viatris mission of empowering people worldwide to live healthier at every stage of life and works with his colleagues diligently to deliver on the mission. In addition to his professional life, Deva is an avid sports enthusiast and a passionate bike rider. He loves the US Sports national leagues NFL, NBA and follows ATP games religiously. His favourite pass time habit is riding his Harley V Rod and Suzuki Hayabusa.
• 

  Mahesh R. Ramanadham, PharmD, MBA

  Deputy Director, CDER/OPQ/US FDA

  Read Bio
  

  Mahesh R. Ramanadham, PharmD, MBA

  CDER/OPQ/US FDA

  Commander (CDR) Ramanadham is the Deputy Director for the Office of Policy for Pharmaceutical Quality, within the Office of Pharmaceutical Quality (OPQ). He joined the Agency in November 2009 after graduating with his Doctor of Pharmacy degree from the University of Maryland and his M.B.A. from the University of Baltimore. Within FDA, he has served in leadership roles in the Office of Compliance and the Office of Pharmaceutical Manufacturing Assessment within OPQ. Prior to joining FDA, CDR Ramanadham had experience in solid oral dosage manufacturing ranging from OTC products to schedule II narcotics. Outside of FDA, CDR Ramanadham continues to practice pharmacy in the community setting to maintain perspective on the clinical relevancy and impact of our efforts in pharmaceutical quality.
• 

  M. Madan Mohan Reddy

  Whole Time Director, Aurobindo Pharma Limited

  Read Bio
  

  M. Madan Mohan Reddy

  Aurobindo Pharma Limited

  M. Madan Mohan Reddy has a Master’s Degree in Science (Organic Chemistry) and held top managerial positions in leading pharma companies. He brings valuable experience in regulatory affairs of the pharma industry. Prior to joining the Company,  he was working as the Managing Director of M/s. Srichakra Remedies Limited.
• 

  Dr. Carmelo Rosa

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

  Read Bio
  

  Dr. Carmelo Rosa

  CDER/OMQ/US FDA

  Carmelo Rosa, Psy.D, Director Division of Drug Quality I - holds a BS/MS, and a doctoral degree as a Clinical Psychologist.  He has been with the FDA for 33 years. In1990, he started as an Investigator for the Los Angeles DO. Worked for approx. 18 years as a drug Investigator, CO and member of the foreign drug inspection cadre. He conducted complex drug inspections and many criminal investigations that resulted in significant actions (e.g., WLs, Seizures, IA, CD, Prosections & Injunctions). In 2008 he transferred to the DC area. He served as a CO, TL, BC and is the Director for the Division Drug Quality I. Dr. Rosa is the former Chair of the PIC/S API Expert Circle and Professor Federal Laws enforced by FDA. He has served as a US Gov. GMP Expert Witness and CGMP trainer. He works very closely with International Regulatory Authorities. He is a frequent speaker in domestic and international conferences. Dr. Rosa is responsible for the review of inspection reports related to drug manufacturing facilities that may result in a regulatory action. On his free time he is a bass/guitar player, serves as a Licensed Psychologist, and enjoys cooking and being with his family.

• 

  Dr. Anil Sawant

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

  Read Bio
  

  Dr. Anil Sawant

  Merck Sharpe & Dohme, USA

  Dr. Anil Sawant has more than 30 years of experience in the pharmaceutical industry in Quality & Compliance, Pharmaceutical Microbiology, Business Ethics, Auditing, and R&D functions.  He has worked on various dosage forms, and various product types, drugs, biologics, vaccines, medical devices, and consumer products.  He was of the teams that launched the first antibody-drug conjugate product and first photoactive drug in the US.   Currently, Anil is Sr. Vice President, Global Quality Transformation, Merck Sharpe & Dohme. He is currently focused on digital transformation of GMP systems supporting supply chains to increase global patient access.  Prior to joining MSD, Anil served in senior executive roles at Johnson & Johnson and at Pfizer. Anil has been a PDA Member and volunteer since 1992.  and is currently the Chair-Elect, PDA Board of Directors.   He is co-authored numerous PDA Technical Reports and position papers and lead the Data Integrity and COVID-19 Task Force. He has also published numerous scientific papers in infectious diseases, antimicrobials, and yeast physiology. Anil holds a B.Sc. Honors and a M.Sc. Honors in Microbiology & Biochemistry from Panjab University, India, and a PhD in Microbial and Biochemical Sciences from Georgia State University, Atlanta. He is recipient of the GSU Distinguished Alumni Achievement Award. Anil serves on the Board of the non-profit Mind Your Brain Foundation and has served on the Board of Directors of GSU Alumni Association.

• 

  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.

• 

  Vikram Shukla

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

  Read Bio
  

  Vikram Shukla

  Pfizer

  An Injectable expert with more than 28 years in the field of Quality and Operations. He has previously worked with various multinational organizations such as Dr. Reddy’s, Lupin, Fresenius Kabi, Hospira, and Zydus. Presently working as Vice President - Sterile Injectable and Biotech Operations – APAC Cluster, taking care of Pfizer’s Injectables operation in Australia, India and China.

  Vikram is also serving as Board of Director for Pfizer Healthcare India Pvt Ltd, India and Zydus Hospira Oncology, India.

  Vikram is a postgraduate in Microbiology from the University of Mumbai having expertise in Operations activities, Quality Assurance, GMP and Microbiology.

  Closely associated with Injectable manufacturing facilities and has also worked in Solid orals and all forms of Injectable -SVP, LVP and Dry Powder, Lyophilized products, as well as Active Pharmaceuticals Ingredients (APIs) including Sterile APIs.

  Some of strengths demonstrated are culture building, Productivity and quality improvements along with strong decision making.

• 

  Stephen Tyrpak

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

  Read Bio
  

  Stephen Tyrpak

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

  Stephen is a healthcare executive and commercialization expert with over 15 years’ experience working with pharmaceutical, medical device, and combination products, supporting companies in the US and around the globe in various areas requiring his expertise.  Stephen has spent years corroborating with an array of different specialties including, but not limited to, creating and optimizing global cGMP quality systems specifically focused on Aseptic Manufacturing and creating robust Manual Visual Inspection (MVI) and CAPA programs. He acts as US agent for global Pharmaceutical and Medical Device companies and provides support in the preparation and possible remediation required as a result of Regulatory Inspections. He has assisted startup companies from around the globe in raising over $120 million in commercial seed funding and over $12 million in US state and federal grants often used to bring novel therapies to market. He is recognized as a commercialization expert, senior Business Advisor, and is an invited speaker and panel expert in the areas of regulatory affairs, MVI, GXP compliance and startup business strategy. He is a peer reviewed published author, keynote speaker, a member of the Medical Device Manufacturers Association (FDA and Compliance Working groups) and sits as the Chair of D'Youville Universities' Founders Board for their School of Medicine, on The University at Buffalo's CBLS & CAT Industrial Advisory Board & on the Board of Directors for the Mental Health Advocates of Western New York (WNY). He was one of WNY’s 30 under 30.
• 

  Jeff Yuen, MPH

  President and CEO, Jeff Yuen & Associates, Inc.

  Read Bio
  

  Jeff Yuen, MPH

  Jeff Yuen & Associates, Inc.

  CDR Jeff Yuen is a highly regarded figure in the field of compliance and regulatory affairs with over 32 years of experience. He served as a peace officer/investigator with the State of California, Food and Drug Branch, and later as a Consumer Safety Officer for the US FDA. During his tenure with the FDA, CDR Yuen achieved the rank of Commander in the US Public Health Service, holding key roles in various teams, including the FDA’s Pacific Regional Biotech Team, Foreign Inspection Cadre, and as the Los Angeles District Pre-Approval Manager and Drug Team Leader. His expertise lies in CGMP and compliance, particularly in sterile drug manufacturing, biotech products, aseptic filling, quality systems, and process validation. CDR Yuen has received numerous commendation and achievement medals from the US Public Health, including a "Hammer Award" from Vice President Al Gore's Office for his leadership in innovative biotechnology/FDA industry outreach programs. Since leaving the FDA in 1998, CDR Yuen founded Jeff Yuen & Associates, Inc., an independent consulting firm with a team comprising former FDA National Experts, industry experts, investigators, chemists, biologists, and microbiologists. He has also served as an acting transitional executive at various companies, holding roles such as Head of Quality at Althea Technologies (now Ajinomoto Althea), Executive Vice President of Global Quality for AAI Pharma / Cambridge Major Laboratories (now Alcami), Chief Quality Officer for Alexion Pharmaceuticals, Inc., and Executive VP for Hanmi Pharmaceuticals (Korea). Known for his mentoring, coaching, and teaching skills, CDR Yuen is recognized globally for his ability to collaborate with Operations and QA, drive organizational change, and emphasize the importance of "right first time" and proper root cause investigations in quality systems. He holds a BS in Biological Sciences from UCI, a Masters in Public Health from UCLA, and an MBA from National University. CDR Yuen is a past President of the PDA – Southern California Chapter and has received the "Distinguished Alumni" award from the School of Biological Sciences at the University of California, Irvine. Currently, he sits on several executive advisory boards, including the UC Irvine School of Pharmacy Dean’s Leadership/Advisory Council.