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Become a Volunteer

Standard Practice for Quality Risk Management of Aseptic Processes (New Standard)

Type:
  • Standards Development
Application Deadline: 28 Mar, 2019
Location:
  • Virtual
  • In Person
Bethesda, Maryland
Openings: 20

Description

PDA is very pleased to announce the launch of the Parenteral Drug Association's third standard! We are seeking volunteer participants to assist in developing, writing, and fine tuning the Standard Practice for Quality Risk Management of Aseptic Processes (New Standard) .

Scope

This is a practical standard to guide industry and regulators seeking to apply, or evaluate, Quality Risk Management principles in decisions related to:

  • Planning,
  • Design,
  • Qualification,
  • Operation,
  • Monitoring, and investigation of the various aspects of Aseptic Processing.

This proposed American National Standard (ANS) was presented by Mr. Hal Baseman, Chief Operating Officer, ValSource Inc.

Who Should Apply

Those individuals involved in Quality Assurance, Quality control, Quality Engineering, Operations, Production and Manufacturing, MSAT and Process Development, Engineering and Maintenance, Validation, Regulatory, International Health Authority Reviewers and Inspectors are being sought.

Skills

  • Project Management
  • Technical Writing/Editing
  • Quality & Compliance
  • Regulatory Affairs

Requirements

  • CV
  • *Completed contact form 

*The contact form will be provided by the PDA Standards Manager at standards@pda.org.