PDA is very pleased to announce the launch of the Parenteral Drug Association’s sixth standard! We are seeking volunteer participants to assist in developing, writing, and fine tuning the following proposal:
Standard 06-201x, Quality Culture Assessment Tool (new standard).
A comprehensive Quality Culture Assessment Tool and Training, designed to guide companies to a better understanding of quality culture, how to assess it, and what actions to take to improve it. The tool helps a company effectively collect verifiable data that will help them to assess their culture at all levels of their organization. The tool allows the company to facilitate positive culture changes and continuous improvement within their organization.
This proposed American National Standard (ANS) was presented by Susan Schniepp, Distinguished Fellow with Regulatory Compliance Associates.
Those individuals involved in Quality Assurance, Quality Control, Quality Engineering, Operations, Production, and Manufacturing, Regulatory, and General Interest are needed.
Nominations/Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard.
- Project Management
- Technical Writing/Editing
- Packaging Science, Container Closure
- Process Engineering
- Quality & Compliance
- Sterile Processing
- Regulatory Affairs
- Auditing/Inspection Response
- ATMP/Gene and Cell Therapy
- *Completed contact form
*The contact form will be provided by the PDA Standards Manager at [email protected].