2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference

Sustainable Implementation of Quality Risk Management

The global pharmaceutical industry continues to face unexpected challenges in responding to the world’s pandemic. The impact on normal operations has been felt in companies of all sizes, with varying types of manufacturing capabilities, no more intensely than in the Asia Pacific region. The 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will address this impact and the most critical issues, with special emphasis on practical application using a series of case studies implementing Quality Risk Management principals.

As companies in this region adapt to new interpretations of existing regulations, contend with remote inspections, and manage an increasing number of CMOs, effective quality risk assessment and risk mitigation have become exponentially more significant. Full transparency with regulatory agencies and comprehensive responses to regulatory actions is imperative to ensure product quality, safety, and efficacy.


Here's What to Expect


Featured Speakers


Special ISPE Member Offer

ISPE Members can save up to $145 and get exclusive on demand access* to the 45-minute session "Data Integrity in Quality Systems & Automated Technology" featuring:

  • R. Derek Glover, Head of Global Quality, Viatris
  • James Strickland, Senior Director, Data Integrity Program Lead, Pfizer Inc. 

Just use code APAC21 at checkout to secure your video access. Hurry, this offer expires after 16 April 2021.

exclusive on demand access

Watch Session Preview

*On demand access to the 45-minute session "Data Integrity in Quality Systems & Automated Technology" will be available 21 April 2021 through 21 May 2021. You will receive access details via email on 21 April 2021.


Why Attend?

At the conclusion of the conference, attendees will be able to:

  • Implement quality risk management principles in addressing OOS investigations, cross contamination, data review, and aseptic processing controls
  • Navigate distance assessments, audits, and alternative avenues for reviews
  • Develop comprehensive responses to regulatory actions
  • Enhance the culture of transparency during interactions with regulatory agencies
  • Effectively manage CMO/CDMO relationships and product quality

Topics

Conference

  • Quality Risk Management: Beyond Theory to Sustainable Implementation
  • Case Studies in Implementing Quality Risk Management & Risk Assessment
  • Adapting during the Pandemic: Changing Regulatory Processes and Industry Experience
  • Creating Comprehensive Responses to Regulatory Actions
  • CMO/CDMO Relationships, Management, and Quality
  • Achieving Full Transparency with Regulatory Agencies

Case Study

  • Practical Applications for Out-of-Specification Investigations/Assessments
  • Cross Contamination Controls
  • Critical Review of Quality and Manufacturing Data
  • Aseptic Processing Controls

Why Attend Virtually

  • Feel like You're In-Person with a Fully Interactive Digital Experience
    Our event portal is easy to navigate and will allow you to view presentations, access PDFs of the presentations, take downloadable notes in each session, participate in polls, chat with other attendees, and participate in LIVE Q&A sessions with speakers.
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  • Build Your Experience
    Add the sessions you want to attend with the click of a button to build your own custom agenda.
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  • Gain Actionable Insights
    Global experts will be at your fingertips sharing their knowledge and lessons learned on advanced therapeutic medicinal products (ATMPs) including cell and gene therapies, digitalization, single-use technology, implications of ICH Q12 for biopharma, and much more.
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Virtual Event FAQs


Who Should Attend

  • Manufacturing and Operations professionals
  • Quality Assurance professionals 
  • Quality Control professionals 
  • Regulatory Body personnel
  • Regulatory Affairs experts 
  • Pharma Senior Level Managers
  • Executive Level Leaders in Pharmaceutical and Bio Manufacturing

Receive Notifications

Stay up-to-date on registration, education opportunities, speakers, hotel discounts, exhibitor information, and more by signing up to receive notifications for the 2021 ISPE APAC Pharma Manufacturing Virtual Conference

Name
Company Type

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
David Churchward
Deputy Unit Manager, Inspectorate Strategy & Innovation
MHRA
Antonio C. Crincoli, PE
Head of Global Engineering IOAO Division
Viatris
Deva H. Puranam
Head of Global Quality Investigations
Viatris
Georg Singewald, PhD
VP, Head of Global Quality Control
Genentech, A Member of the Roche Group
Aditi S. Thakur
Acting Quality Assessment Lead
FDA/CDER/OPQ/OPF