2022 PDA Asia Pacific Regulatory Conference

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The much awaited inaugural 2022 PDA Asia Pacific Regulatory Conference and Workshop, will be held virtually 15-17 November 2022. Hear, experience and learn from the regions' top global regulators and industry experts on topics such as:

Electronic submissions - current status, opportunities and challenges in Asia Pacific
Attribute based approach - managing risk, alternate sources of raw materials, logistics, supply chain integrity
Post approval changes - what to do when change of facility, facility scale up, improvement in process
Audit trail review - general principles, frequency, timeliness, depth, responsibilities.

Who Should Attend?

Auditors, Audit Specialists, Audit Managers, BioMonitoring Specialists, Biotech Managers, Head of Plant, Managing Directors, Production Manager, Quality Assurance Managers, Quality Control Managers, Quality Control Supervisors, Quality Operations Managers, Research & Design Specialists, Regulators, Regulatory Compliance Managers, Senior Consultants, Senior Managers, Technical Account Specialists, Unit Managers

Agenda

Tuesday, November 15, 2022 10:00 to 19:00: 10:00 - 10:15
Opening Ceremony; 10:15 - 10:20
E-Submissions: Opportunities and Challenges - Introduction by the Moderator; 10:20 - 10:50
Using AI/ML for Optimising Regulatory Operations; 10:50 - 11:20
The Evolution of Regulatory Review towards Data Collaborative Review with Accumulus; 11:20 - 12:00
Panel Discussion and Q&A

Wednesday, November 16, 2022 10:00 to 17:10: 10:00 - 10:05
Audit Review - Introduction by the Moderator; 10:05 - 10:35
The Good News about FDA's Quality Management Metrics (QMM) and Our Data Governance Journey; 10:35 - 11:05
Data Governance and Quality Culture; 11:05 - 11:35
Data Integrity; 11:35 - 12:15
FDA Quality Management Maturity White Paper

See full agenda