The 2015 PDA Single Use Systems Workshop will showcase how to implement a risk-based decision making process for meeting regulatory expectations while using single use systems (SUS), and will present critical points to consider when implementing SUS.

Tor Gråberg, Chief Pharmaceutical Inspector, Head of Drug Inspectorate, MPA, will speak about the challenges and needs for SUS practices, focusing on the pitfalls and regulatory concerns regarding implementation of single use technology from the perspective of an EU regulator.

This valuable workshop uses the individual chapters of PDA’s Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing, as the basis for the sessions,  presenting perspectives of end users, manufacturers, suppliers and industry enablers, resulting in a balanced, well- vetted, consensus viewpoint on regarding the most important information on implementing SUSs, including: 

• Supply and Quality Concerns: Case studies will show how a transparent relationship between SUS suppliers and pharmaceutical manufacturers is required for successful implementation of SUSs.
• Implementation and Deployment: Learn how to implement a risk-based decision making process for the use of SUSs and the potential impact.
• Points to Consider for SUS Implementation: This two-part session discusses the standards for specification designs, critical points to consider, best practices and the U.S. FDA’s perspective on quality attributes.
• Ask the Regulators Panel Discussion: A unique opportunity to engage directly with regulators regarding the expectation of regulators on the application, use and validation of SUSs.

Get the latest information and best practices from the leading authority on SUSs at the 2015 PDA Single Use Systems Workshop, where you’ll gain important knowledge as the industry shifts to a new way of producing life-saving drug products. Reserve your seat today!

Immediately following the workshop, PDA Education will hold the 2015 PDA Single Use Systems Workshop Course Series. Learn critical concepts to consider when implementing an SUS strategy at the Single Use Systems for the Manufacturing of Parenteral Products course [June 25-26] or gain the knowledge of dealing with issues regarding Extractables/Leachables in a responsible, scientific, and cost-effective manner at the Assessing Packaging and Processing Extractables/Leachables [June25-26] course.

With such a value-added opportunity to increase your knowledge on SUSs, the hardest choice you’ll make today is which course to attend!