ValSource Experts Present on Global Sterile Product Manufacturing

Chief Operating Officer Hal Baseman and Director of Learning Solutions James Vesper are featured presenters at the 2017 Parenteral Drug Association Annex 1 Workshop. The workshop, being held October 2-3 at the Omni Shoreham Hotel in Washington, D.C., is designed to present the newly released draft revision to EU Annex 1, Manufacture of Sterile Medicinal Products of the European Union Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use.

“Make no mistake. This critical revision will impact sterile manufacturing processes worldwide,” Baseman commented. “Understanding the content of expectations of global health authorities places those responsible for sterile product manufacturing in a much better position to navigate the challenges of modern aseptic processing.”

Baseman will deliver opening remarks and present the session: Industry Perspectives: Challenges and Opportunities. James Vesper’s session—What Scares Us About Risk? How Risk Tolerance Impacts our Thinking About Aseptic Processes—examines research on risk perception and how it can apply to producing sterile drug products.  Vesper commented, “The presentation is designed to stimulate thinking on how factors—such as understanding the hazard and trust in the source of information—affect the amount of risk we are willing to accept. We need to know how our experiences and unintentional biases can affect the decisions we are making.”

The workshop brings together regulators, contributors, industry experts, and the actual personnel who must implement the new requirements, with the purpose of reviewing the content of the revised Annex, focusing on the most critical changes and regulatory expectations, and their impact on the daily operations of global manufacturers of sterile products.