Ensuring Product Quality & Compliance Alongside Analytial Development in Preparation for IND Submissions

Time: 2:30 pm
day: Conf Day One QPD PM


  • 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