Reset
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
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

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

Tuesday

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

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

Tuesday

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

Wednesday

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

Wednesday

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

Wednesday