Development work on BSR/PDA Standard 06-201x: Quality Culture Assessment Tool, PDA’s sixth standard, will begin April 20 under the guidance of PDA Chair-Elect Susan Schniepp, a distinguished fellow at Regulatory Compliance Associates. This new standard will take the form of a comprehensive quality culture assessment tool and training, designed to guide companies toward a better understanding of quality culture, how to assess it and what actions to take to improve it.
Fashioned after the assessment tool and training course offered by PDA, companies will be able to use the standard to help collect and measure the verifiable data needed to assess quality at all levels of an organization. The resulting information can then be used to facilitate positive culture changes and support continuous improvement, so the entire organization recognizes the importance of providing patients with high-quality medicinal products.
The expertise of the group members covers a broad range of experience, from quality assurance to engineering to production to global regulation. The members are listed below.
For updates on this and other PDA standards, visit the PDA Standards Development website.