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

9

April

  • 3PM London / 10AM New York
  • Free
  • Why attend?
  • Speakers
  • Contact Us

Why attend?

Learning Objectives:

  • Understand the FDA Regulatory Landscape: Gain a comprehensive overview of the FDA approval process and the specific compliance requirements that European drug manufacturers must meet to successfully launch in the U.S. market.
  • Master Cold Chain Logistics for FDA Compliance: Learn how to implement robust cold chain solutions that ensure product integrity and compliance with FDA guidelines.
  • Identify and Mitigate Risk Factors: Discover the most common pitfalls in the FDA submission process and learn proactive strategies to minimize risks, avoid delays, and ensure a smooth approval process
  • Develop a Roadmap for a Successful U.S. Launch: Walk away with actionable steps to streamline your product launch process, from submission preparation to logistics, ensuring a stress-free transition to the U.S. market.

 

Entering the U.S. market comes with a unique set of regulatory challenges, particularly when it comes to meeting FDA compliance standards around transport validation and cold chain. For European drug manufacturers, navigating these hurdles is often daunting. Learn how to avoid sleepless nights worrying about compliance missteps, unexpected delays, and the potential risk of product rejection. This webinar will provide insights into the critical areas of transport validation where many manufacturers face challenges and offer practical strategies to mitigate them.

Join Robert Battista and Carson Dickey and Rachel Sawyer, experts in FDA regulatory compliance and cold chain engineering, as they guide you through the key steps to ensure a successful product launch in the U.S. You’ll gain:

  1. A clear understanding of FDA transport validation and cold chain requirements for European manufacturers.
  2. Strategies for implementing seamless logistics and cold chain solutions.
  3. Tips to reduce risk and ensure compliance, including unique challenges of distributing in America, so you can sleep soundly throughout the process.

Don’t miss this opportunity to equip yourself with the knowledge and confidence to launch your product in the U.S. with ease. Secure your spot today and take the first step toward stress-free FDA compliance.

Speakers

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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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​​Rachel Sawyer​
​​Principal Engineer​, Modality Solutions

​​Rachel is a Modality Solutions SME, working directly with clients to ensure proper design of logistics networks and use of cold chain systems. She provides engineering guidance when conducting qualification and validation activities, including validation master planning and strategic facility planning. Rachel conducts product specific supply chain risk assessments and has experience supporting 10+ successful regulatory approvals including NDAs for small molecules and BLAs for mAbs, ADCs, vaccines, and a cell therapy in the US (FDA), EU (EMA), and UK (MHRA) with fast track and breakthrough therapy designations as well as accelerated approval pathways.

Rachel reviews and writes SOPs for cold chain related processes to meet regulatory requirements for transport validation, drafts protocols and reports for testing and validation of processes, reviews data packages for reports, and conducts in-person cold chain consulting services and GDP site assessments.

She was also part of the Modality team supporting emergency clinical trial operations with Ebola vaccines and treatments for the NIH and BARDA in the Democratic Republic of the Congo and Liberia. Rachel was the lead engineer for the COVID-19 clinical trial project, coordinating with the trial sponsors, CROS, and clinical site staff, traveling to conduct cold chain assessments, recommend site-selection for clinical trials, and ensure adequate deep-frozen storage was available in the USA, India, South Africa, Peru, Colombia, Panama, and Puerto Rico. 

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