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ComplianceOnline

This 3 hour webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program. The webinar will discuss how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

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ComplianceOnline

The program will explain how to determine the needed elements of a quality management system, how to decide which procedures are necessary, and how to configure the system for future growth. The program will also cover the FDA inspection process, and introduce participants to key FDA documents that explain the process in detail and facilitate effective preparation and management of FDA inspections.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

Introduction to FDA law, regulation and GXP Concepts, Fundamentals of Good Manufacturing Practice, Data Integrity: What it is and why it is important to GMP, Building a GXP Quality Management System, Selection qualification and monitoring of contractors, Phase appropriate GMP considerations – investigational drugs vs commercial, Preparing for and Managing FDA Inspections, Enforcement considerations

ComplianceOnline

This seminar will help all personnel responsible for CMO oversight understand how to ensure effective quality oversight of CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, CMO Audits, Quality Agreements, Oversight of CMO Operations, and Review of Key CMO Records. Considerations for different types of manufacturing will be highlighted, and techniques for managing difficult CMO situations will be addressed. Techniques for assuring robust CMO Oversight programs in light of COVID-19 restrictions will also be discussed.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

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