2020 ISPE APAC Pharma Manufacturing Virtual Conference

Sep 21, 2020 ‐ Sep 23, 2020


The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference and Executive Forum provides you with access to regulatory intelligence on emerging supply chain, quality, and compliance challenges in light of COVID-19. Participate in actionable, interactive discussions featuring case studies and dedicated Q&A time with experts representing global health authorities, including FDA and MHRA.

Benefit from unparalleled real-time engagement with regulatory leaders as they share companies' best practices to assess critical manufacturing processes and lessons learned to improve and sustain a reliable supply of quality medicine. Plus, stay knowledgeable throughout the year with on demand access to ALL session recordings and presentations for 12 months.


Sessions

Executive Forum - Trends in Supply Chain Visibility & Control - Part 1

Sep 21, 2020 7:30am ‐ Sep 21, 2020 9:00am

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.

Session Leader(s): Speaker(s):

Executive Forum - Trends in Supply Chain Visibility & Control - Part 2

Sep 21, 2020 9:10am ‐ Sep 21, 2020 9:30am

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.

Speaker(s):
  • Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

Executive Forum - Case Study Breakout Discussions - Part 3

Sep 21, 2020 9:40am ‐ Sep 21, 2020 10:20am

Executive Forum - Case Study Breakout Discussions - Part 3 | Attendees are registered for a single case study to engage in discussion on specific scenarios designed by the FDA.

Speaker(s):
  • Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

EXECUTIVE FORUM: Case Study Report-Outs and Panel Discussion - Part 4

Sep 21, 2020 10:30am ‐ Sep 21, 2020 11:30am

Speaker(s):

Opening Plenary: Quality & Compliance (ICH Q10/Q12) and Risk Mitigation

Sep 22, 2020 4:30am ‐ Sep 22, 2020 6:30am

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.

Session Leader(s): Speaker(s):

Supply Chain Visibility and Control Part I

Sep 22, 2020 6:45am ‐ Sep 22, 2020 7:25am

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.

Session Leader(s): Speaker(s):

Cleaning Validation and Cross Contamination Control

Sep 22, 2020 6:45am ‐ Sep 22, 2020 7:45am

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.

Session Leader(s): Speaker(s):

Out-of-Specifications (OOS) Investigations

Sep 23, 2020 6:15am ‐ Sep 23, 2020 7:30am

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.

Session Leader(s): Speaker(s):

Data Integrity in Quality Systems & Automated Technology

Sep 23, 2020 8:30am ‐ Sep 23, 2020 9:25am

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.

Session Leader(s): Speaker(s):

Aseptic Processing Design, Operations, and Controls

Sep 23, 2020 8:30am ‐ Sep 23, 2020 9:25am

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.

Session Leader(s): Speaker(s):
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