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2021 - Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Date2021-04-13 - 2021-04-14
Deadline2021-04-03
Venue, USA - United States 
KeywordsContract drug manufacturers; Pharma contract manufacturers; CMO business model
Topics/Call fo Papers
Understand the CMO business model
Understand the regulatory requirements for CMO quality oversight
Understand how to structure your organization for effective CMO oversight
Understand key points for selecting and qualifying CMOs
Know how to prepare for and conduct CMO Audits
Know how to develop a Quality Agreement and how to execute it
Understand key points for reviewing CMO records
Know how to resolve issues identified in CMO records
Know how to manage CMOs on an ongoing basis
Understand the regulatory requirements for CMO quality oversight
Understand how to structure your organization for effective CMO oversight
Understand key points for selecting and qualifying CMOs
Know how to prepare for and conduct CMO Audits
Know how to develop a Quality Agreement and how to execute it
Understand key points for reviewing CMO records
Know how to resolve issues identified in CMO records
Know how to manage CMOs on an ongoing basis
Other CFPs
- Management Controls Under QSR and ISO 13485
- CAPA is Not a 4 Letter Word: Establishing an Effective and Efficient CAPA Process
- Calculations for Process and Product Capability
- The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301
- Essential Elements of a Successful Clinical Documentation Improvement (CDI) Program
Last modified: 2021-04-03 22:01:09