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.
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.
*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
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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.
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
Program Committee
Event Sponsors and Supporters
