This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
Course Objective:
Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.
This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective. Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. Comparison of the two regulatory documents will be presented with differences highlighted and discussed. The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.
Course Outline:
What You Get:
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
LIVE : Scheduled on
02-April-2024 :01:00 PM EDT
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GMPs for Medical Devices and Key Medical Device Observations
LIVE : Scheduled on
10-April-2024 :01:00 PM EDT
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4-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc-)
LIVE : Scheduled on
10-April-2024 :01:00 PM EDT
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4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
LIVE : Scheduled on
18-April-2024 :01:00 PM EDT
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Impact Assessments and Risk Management for Change Control
LIVE : Scheduled on
24-April-2024 :01:00 PM EDT
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