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PDA® Standards Development Call for Volunteers

                         

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. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.  The deadline to submit notification of interest in serving on the consensus body is January 14, 2020.  

Latest Discussions

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    review

    ​few minor comments and questions ------------------------------ Daniel Eshete Principal Scientist Pall Biotech Westborogh MA 5162035858 ------------------------------

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    Re: ASN-0004 Appendices to edit uploaded

    Hi All,  I also added few minor comments/edits. Thanks. Kang ------------------------------ Kang Cai Principal Scientist AstraZeneca Gaithersburg MD 301-398-3830 ------------------------------

  • Submitter's message I made some edits in the text and made a few comments. I think we can streamline the methods a lot since the majority of the growth and enumeration methods for both phages are the same. -- Scott Lute ...