Launching in the U.S.: FDA Transport Validation Compliance Essentials for European Manufacturers

Everything you need to know for a smooth and stress-free FDA approval process

11

March

  • 3PM London / 10AM New York
  • Free
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Robert Battista
Engineering Manager, Modality Solutions

In his Engineering Manager position with Modality Solutions, Robert is responsible for onboarding and mentoring new engineers as well as the creation of additional business opportunities and cutting-edge research into cold chain hazards and solutions. Robert also works directly with clients to strategically create the proper validation of their cold chain systems through risk and gap analysis and subsequent mitigation plans. He then implements the validation master plan through the creation of standard operating procedures, qualification of critical equipment, validation of processes, and in-person training for essential personnel.

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Carson Dickey
Engineering Manager, Modality Solutions

Carson is an expert in cold chain engineering and biopharmaceutical shipping validation and is passionate about developing risk-based validation strategies, qualifying thermal packaging, and designing transport simulations. He has been involved in regulatory submissions for commercial approval of biopharma products worldwide and has received over 30 approvals for products where he was responsible for developing shipping validation strategies. His work in cold chain engineering has also made him an expert at assessing thermal packaging qualifications and performing heat transfer analysis to apply existing studies to new products. Carson serves as the co-chair for the International Society of Cell and Gene Therapies - Process Development and Manufacturing Committee – Cold Chain Logistics and Management Working Group. Additionally, he is a member of the International Safe Transit Association (ISTA) Pharma Committee and most recently, has co-authored the supply chain risk assessment guidance whitepaper.

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