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Monday
07:30am - 09:00am EDT - September 21, 2020
Frances M. Zipp, Session Leader, President & CEO, Lachman Consultant Services; Carmelo Rosa, PsyD, Session Leader, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ; Deva H. Puranam, Speaker, Head of Global Quality Investigations, Viatris; Caroline Rocks, CEng, Speaker, Senior Program Manager, AbbVie, Inc.; José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA; Mr. Antonio C. Crincoli, PE, Speaker, Vice President of Global Engineering, Catalent Pharma Solutions; Christopher T. Middendorf, Speaker, International Relations Specialist / Diplomat At FDA, FDA/OC; Aditi S. Thakur, Speaker, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF; Letitia Robinson, PhD, Speaker, Country Director, India Office, FDA/ORA; Johnny Mikell, Speaker, Head of Global Quality, Lupin Pharmaceuticals, Inc.; Rajendra B. Chunodkar, Speaker, Head of Manufacturing Operations, Lupin Laboratories Pvt Ltd; David Churchward, Speaker, Head of Operations Quality, Compliance and External Affairs, AstraZeneca; Rajiv Malik, Speaker, President, Viatris
Executive Forum - Trends in Supply Chain Visibility & Control - Part 1 | The Executive Forum, led by global regulators and industry leaders, is an interactive discussion forum for pharmaceutical executives. The focus of this year's Forum will be on assessing the impact of COVID-19 on the pharmaceutical supply chain and lessons learned for the pharmaceutical manufacturing industry.

Monday
09:10am - 09:30am EDT - September 21, 2020
Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
Executive Forum - Trends in Supply Chain Visibility & Control - Part 2 | Hear recommendations from the FDA for developing a comprehensive, sustainable supply chain visibility and control strategy.

Monday
10:30am - 11:30am EDT - September 21, 2020
Frances M. Zipp, President & CEO, Lachman Consultant Services; José E. Meléndez, Consumer Safety Officer, FDA/ORA; Mr. Antonio C. Crincoli, PE, Vice President of Global Engineering, Catalent Pharma Solutions; David Churchward, Head of Operations Quality, Compliance and External Affairs, AstraZeneca; Christopher T. Middendorf, International Relations Specialist / Diplomat At FDA, FDA/OC; Deva H. Puranam, Head of Global Quality Investigations, Viatris; Caroline Rocks, CEng, Senior Program Manager, AbbVie, Inc.; Aditi S. Thakur, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF; Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

04:30am - 06:30am EDT - September 22, 2020
Frances M. Zipp, Session Leader, President & CEO, Lachman Consultant Services; Christiane Hamacher, PhD, Speaker, CEO & Managing Director, Biocon Biologics India Ltd; David Churchward, Speaker, Head of Operations Quality, Compliance and External Affairs, AstraZeneca
Opening Plenary: Quality & Compliance (ICH Q10/Q12) and Risk Mitigation | In the Opening Plenary session, presenters from international regulatory authorities and industry representatives will discuss application of manufacturing strategies that align with principles outlined in ICH Q10 and Q12. Presenters will cover how pharmaceutical quality systems and risk management concepts applied over the entirety of a multinational firm’s operations align with the expectations of global regulators.

Tuesday
04:35am - 05:05am EDT - September 22, 2020
Christiane Hamacher, PhD, Speaker, CEO & Managing Director, Biocon Biologics India Ltd

Tuesday
05:05am - 05:35am EDT - September 22, 2020
David Churchward, Speaker, Head of Operations Quality, Compliance and External Affairs, AstraZeneca

06:45am - 07:25am EDT - September 22, 2020
Mr. Antonio C. Crincoli, PE, Session Leader, Vice President of Global Engineering, Catalent Pharma Solutions; Sarah McMullen, PhD, Speaker, Deputy Director, FDA
Supply Chain Visibility and Control Part I | Successes and Lessons Learned will be provided by the leadership of key manufacturers on their current COVID-19 experiences to insure a reliable supply chain of critical medicines. All manufacturers are dealing with supply chain shortages in critical components, APIs, excipients, especially materials outside their specific regions. How has limited access, need for flexibility, redundancy and even shortages of labor impacted the way they execute. How have they navigated “new” logistics and mitigated the effects of this pandemic and prepared for potentially the next one. Attendees will be able to benchmark the challenges faced by industry peers to ensure the supply of critical medicines during a pandemic.

Tuesday
06:55am - 07:20am EDT - September 22, 2020
Sarah McMullen, PhD, Speaker, Deputy Director, FDA

06:45am - 07:45am EDT - September 22, 2020
David Churchward, Session Leader, Head of Operations Quality, Compliance and External Affairs, AstraZeneca; Ranjana B. Pathak, DHA, Speaker, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.; José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA
Cleaning Validation and Cross Contamination Control | Modern approaches to validation and cross contamination control using the latest technologies and risk-based methods available to the pharmaceutical industry remain under-utilized. This session will deep-dive into the opportunities to modernize approaches to cleaning validation and the current challenges in Commissioning and Qualifying facilities with case studies from recent India facilities.

Tuesday
06:47am - 07:24am EDT - September 22, 2020
Ranjana B. Pathak, DHA, Speaker, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.

Tuesday
07:24am - 07:47am EDT - September 22, 2020
José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA

06:15am - 07:30am EDT - September 23, 2020
Frances M. Zipp, Session Leader, President & CEO, Lachman Consultant Services; Jila Breeze, Speaker, EVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries, Inc.; Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ; José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA
Out-of-Specifications (OOS) Investigations | Why are regulatory inspectors still finding problems in Out-of-Specifications (OOS) investigations? Discussion of real examples will help you and your company to understand the difference between root cause analysis and CAPA. Learn how to establish a reliable and sustainable quality system.

Wednesday
06:20am - 06:43am EDT - September 23, 2020
Jila Breeze, Speaker, EVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries, Inc.

Wednesday
06:43am - 07:28am EDT - September 23, 2020
José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA; Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

08:30am - 09:25am EDT - September 23, 2020
Deva H. Puranam, Session Leader, Head of Global Quality Investigations, Viatris; R. Derek Glover, Speaker, Head of Global Quality, Viatris; James Strickland, Speaker, Senior Director, Data Integrity Program Lead, Pfizer Inc.
Data Integrity in Quality Systems & Automated Technology | Data Integrity is a global issue and currently a major concern with FDA and MHRA and all leading regulatory agencies. Multiple FDA warning letters, MHRA and EU GMP non-compliance reports have highlighted major data integrity failures and data falsification in companies globally. The agencies guidance for data governance has expectations for records in both paper and electronic form and with industry moving towards automation processes, there is a clear need for firms and responsible employees to understand the issues around data integrity and how to build robust systems in both QMS and automation systems.

Wednesday
08:35am - 09:00am EDT - September 23, 2020
R. Derek Glover, Speaker, Head of Global Quality, Viatris

Wednesday
09:00am - 09:25am EDT - September 23, 2020
James Strickland, Speaker, Senior Director, Data Integrity Program Lead, Pfizer Inc.

08:30am - 09:25am EDT - September 23, 2020
Caroline Rocks, CEng, Session Leader, Senior Program Manager, AbbVie, Inc.; Brooke Higgins, Speaker, Senior Policy Advisor for the Global Compliance Branch 3, FDA/CDER; José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA
Aseptic Processing Design, Operations, and Controls | Aseptic processing is one of the most challenging tasks within pharmaceutical manufacturing. There are a wide range of human and equipment factors to keeping the process sterile and compliant. During this session, we review recent findings in warning letters from FDA on aseptic processes and deep dive into a case study on a combination product. You will learn firsthand from two FDA regulators who understand these challenges and deal with them. At the Q&A panel you have a unique opportunity to discuss the challenges you're currently facing and gain some actionable ideas and solutions to improve your own processes directly from the speakers.

Wednesday
08:35am - 09:00am EDT - September 23, 2020
José E. Meléndez, Speaker, Consumer Safety Officer, FDA/ORA

Wednesday
09:00am - 09:30am EDT - September 23, 2020
Brooke Higgins, Speaker, Senior Policy Advisor for the Global Compliance Branch 3, FDA/CDER