Learn How Key Pharma Manufacturers & Suppliers are Dealing with Supply Chain Issues
Ensuring supply of critical medicines during the COVID-19 pandemic has been a severe challenge and tested the limits of the pharmaceutical industry. Join us virtually, along with US Federal and local country Regulators, at the 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum on September 21-23 and discover how key manufacturers and suppliers have experienced and dealt with the latest supply chain issues to sustain reliable supplies of quality medicines.
On Monday, 21 September, we kick-off with an Executive Forum where participants will hear from and enjoy in-depth discussions with pharmaceutical industry leaders on best practices for maintaining pharmaceutical supply chain continuity in a complex and dynamic environment, including:
- Impact of COVID-19 on the pharmaceutical supply chain
- Sustainable supply chain visibility & control strategies
- Post-COVID-19 assessment/lessons learned
- Redundancy in facilities and operations
- Supply chain security in times of crisis
- Global regulatory agency interaction
- Alternate inspection approaches
The 2020 ISPE Asia Pharmaceutical Manufacturing Virtual Conference & Executive Forum starts on Tuesday, 22 September with a plenary session, Quality & Compliance (ICH Q10/Q12) and Risk Mitigation with Live Discussion, where 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. Confirmed and Invited Industry and Regulatory Speakers: BIOCON BIOLOGICS, FDA, MHRA. The entire conference emphasizes open dialogue to give you and your company an opportunity to help your organization.
After the plenary session concludes, the conference continues on with concurrent sessions on key industry topics including:
Supply Chain Visibility and Control – Part I
This session includes successes and lessons learned from leadership at 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.
Cleaning Validation and Cross Contamination Control
This session covers modern approaches to validation 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 validation and the current challenges in Commissioning and Qualifying facilities with case studies from recent India facilities
On Wednesday, 23 September, the sessions continue with:
Supply Chain Visibility and Control, Drug Shortages – Part II
This session provides updates by the FDA on efforts and initiatives developed during the current COVID-19 pandemic to secure the supply chain of critical drugs intended for the US. Current problems have been identified related to the illegal sale of drugs through the internet being marketed to treat COVID-19. In addition, the agency is dealing with everything from a shortage of hand sanitizers in the US, to how pharmacy compounding is being affected by the current pandemic, and the efforts of the FDA Drug Shortages team in mitigating shortages. Attendees will have an opportunity to hear first-hand the challenges the agency faces and the process to ensure that critical drugs are made available to patients during a pandemic and how industry can assist in reducing potential shortages. Key presentations on out-of-specification (OOS) investigations, data integrity controls & remediation, and aseptic processing design, operations and controls.
We wrap up with a closing Regulatory and Industry panel on supply chain, quality, and compliance issues in the wake of the COVID-19 pandemic. Get your questions addressed and engage with these insightful pharmaceutical leaders.
Every session at the 2020 ISPE Asia Pharmaceutical Manufacturing Virtual Conference & Executive Forum includes the opportunity to interact with US federal and local country regulators and industry leaders. Attendees will be able to:
- Assess the impact of COVID-19 on their company’s supply chain visibility and control
- Apply lessons learned from companies impacted by the pandemic in their own organization
- Become current on industry trends in quality & compliance as supply chains evolve
- Work with CMOs to mitigate supply chain disruptions
- Understand quality and regulatory requirements and expectations
- Understand the necessary elements and compliance for quality sustainability
