CLIFTON, N.J., Feb. 7, 2024 /PRNewswire-PRWeb/ — CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is excited to announce that it will be hosting an educational webinar on ISTA and ASTM D4169 Package Distribution Testing specifically for the pharmaceutical and medical device industries. The webinar is scheduled for Thursday March 21st at 10:00am through 11:30am EST and will cover all key and relevant aspects of distribution that effect medical product shipments. This webinar will be hosted by Brandon Zurawlow, Chief Scientific Officer for CS Analytical. The webinar is free of charge and attendees may register here.

“Over the past decade, ensuring the functional and integral properties of medical product shipments has become a key component for the regulatory review process,” noted Brandon Zurawlow, CSO. “The goal of this webinar is to provide key industry players with the background and framework for the development and execution of distribution test programs that ensure regulatory compliance.”

Evaluating the impact of distribution, or transport, on finished goods is not a new concept, as almost everybody can relate to receiving a package only to open it and find the contents damaged. However, evaluating the effects of impacts, compression, vibration, temperature, and high altitude on pharmaceutical and medical device products is something that has only become an expectation from regulatory bodies in recent decades. In addition to straightforward physical damage, these types of products can have unique risks to formulation, product stability, and safety introduced from the distribution process. This CS Analytical hosted webinar will review the general need for distribution testing, unique risks to life science products, current regulatory guidelines and expectations, and industry best practices. International standards by which life science product distribution can be simulated in a laboratory setting will be reviewed (ASTM and ISTA), along with new and pending trends in the unique space of product-package testing using real-world examples. Key learning objectives that will be covered include:

  •     The need for distribution simulation testing for Pharma and Med Device Products
  •     US and EU regulatory guidelines and expectations around distribution testing
  •     Relevant international standards for simulating distribution (ISTA & ASTM)
  •     Future-looking trends and best practices surrounding distribution for a range of product types, including Proteinaceous products and Cell and gene therapies

To register for this no-cost, educational webinar, please follow this link