2020 ISPE Asia Pacific Pharma Manufacturing Conference & Executive Forum

Bracing for Impact: 
Best Practices for Maintaining Pharmaceutical Supply Chain Continuity in a Complex and Dynamic Environment 

The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Conference and Executive Forum will bring together global regulatory and industry thought leaders to share best practices to assess critical manufacturing processes and utilize lessons learned to improve and sustain reliable supply of quality medicines in the wake of the COVID-19 pandemic. The impact on the supply chain, risk management, tech transfer, and a wide range of critical manufacturing operations has been felt across the industry. This event will provide three days of content examining that impact and assessing how the industry has been and should be responding and adapting.

Topics Include

  • Supply chain visibility & control
    • Post-COVID-19 assessment/lessons learned
    • Redundancy in critical manufacturing operations
    • Role of CMOs in mitigating supply chain disruptions
    • Mitigating drug shortages
    • Regulatory expectations for tech transfer
  • Aseptic processing design, operations, and controls
  • Data Integrity controls
  • Cleaning validation and cross-contamination control
  • Out-of-specifications (OOS) investigations
  • Quality & compliance (ICH Q10/Q12), and risk mitigation
  • Process validation for new modalities

Conference-at-a-Glance

Date  
21 Sep 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Executive Forum
22-23 Sep 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Conference
24-25 Sep In-depth classroom training on critical industry topics
Separate registration is required

Learning Objectives

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  

Executive Forum Details

Strategies for Supply Chain Visibility & Control

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 post-COVID-19 assessment of the impact on the pharmaceutical supply chain and lessons learned for the pharmaceutical manufacturing industry.

Learning Objectives

Collaboratively explore opportunities facing pharmaceutical leaders and regulators to develop strategies for enhanced supply chain visibility and control.
 

Topics Include

  • Supply chain visibility and control strategies
    • Post-COVID-19 assessment/lessons learned
    • Redundancy in facilities and operations
    • The role of CMOs in mitigating supply chain issues
    • Drug shortage prevention strategies
  • Clarifying roles and responsibilities: Who is accountable?
  • Dedicating an appropriate and consistent level of resources

Who Should Attend?

Executive Level Leaders in Pharmaceutical and Biopharmaceutical Supply Chain

Manufacturing & Operations professionals Quality Assurance professionals Quality Control professionalsRegulatory Body personnel Regulatory Affairs experts Pharma Senior Level Managers


Program Committee

Carmelo Rosa, PsyD
Director, Division of Drug Quality I
FDA/CDER/OC/OMQ
Co-Chair
Frances M. Zipp
President & CEO
Lachman Consultant Services, Inc
Co-Chair and Board Ambassador
Antonio C. Crincoli, PE
Senior Director, Head Upjohn Global Engineering
Pfizer Inc.
Deva H. Puranam
Head of Global Quality Investigations
Mylan
Caroline Rocks, CEng
Senior Program Manager
AbbVie, Inc.