In the process of drug development, when should you start Good Manufacturing Practices (GMP)/Validation activities? What level of these activities are recommended or required at the different stages of drug development? These stages include; development, clinical phases, and commercialization. The information in this presentation provides assistance with the development of a Validation Program and Validation Master Plan.
This presentation will discuss what level of Validation is required at the different stages of the pharmaceutical product development lifecycle.
Troy Fugate, Vice President, Compliance Insight, Inc.
As the Vice President of Compliance Insight, Inc., Troy works with team colleagues and clients to confirm and facilitate meeting client goals. Troy’s primary strengths are FDA Quality Assurance activities with emphasis in quality systems, risk assessment, facilities and utilities, cleaning, processes, validation and systemic audits. With almost 30 years of experience ranging from foreign audits to consent decree resolution, Troy brings a vast array of knowledge and skills to the discussion.
Who Should Attend?
Professionals involved in the development and manufacturing of FDA regulated drug products and devices from:
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Medical Device Companies
Compliance Insight offers hands-on compliance, quality assurance, clinical and regulatory affairs guidance and consulting that is reliable, accurate, timely and supportive of the client’s goals and compliant with US FDA Regulations.