Advanced CMC In-House Training

This in-house training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex.

Overview

Advanced CMC In-house training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex. This in-house training will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC.

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RECOMMENDATION

Who should attend?

• Quality assurance specialists
• Regulatory Affairs CMC authors or reviewers
• Analytical and stability laboratory managers (R&D through GMP)
• Project managers with CMC responsibilities
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists