Ensuring Product Quality & Compliance Alongside Analytial Development in Preparation for IND Submissions
Time: 2:30 pm
day: Conf Day One QPD PM
Details:
- Defining product compliance and setting the right specifications according to regulatory guidelines
- Detailing the key considerations in assuring product quality – product safety, material origin, and impact of process changes
- Ensuring the correct process control strategy ahead of gene therapy IND submissions