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Parenteral Drug Association Connecting People, Science and Regulation ®

Upcoming Volunteer Opportunities

Volunteer Risk Assessment for Excipients Technical Report

A Formalized Risk Assessment on Excipients is required in the EU to be in place and established to be shown to the Health Authorities since 21st Mar. 2016.

A Risk Management Interest Group "Team Excipients" worked on sharing the principles applied, risk assessment tools and templates being used, challenges been faced during implementation phase.

The task force is now developing a PDA Technical Report on best practices to achieve compliance with the EU requirements. To ensure that this covers a broad spectrum of experience we are reaching out for a few additional volunteers.

Experience/Skills

Current expertise with QRM and GMP principles
Knowledge or expertise with EU requirements
Knowledge or expertise with excipient standards
Ability to write and edit technical documentation
Ability to work and collaborate remotely

Requirements

  • Active PDA Membership
  • Time Commitment.
  • Most team meetings are held virtually with occasional opportunities for face to face discussions.
  • Term based: A Technical Report project is typically an 18 month to 2-year commitment

In case you are interested to contribute, please reach out sending a summary of your expertise in this field and your CV to Karena Grigsby, Volunteer Coordinator volunteer@pda.org by 13 December 2017.


Data Integrity In Manufacturing Systems Technical Report Team

The PDA Data Integrity Task Force is looking for volunteers to contribute to a new Technical Report on Data Integrity in Manufacturing Systems. 

Experience/Skills

  • Current expertise with computerized and paper based systems for manufacturing/shop floor
  • Familiar with applying Data Integrity principles to manufacturing/shop floor processes and systems
  • Knowledge or expertise with GAMP standards
  • Knowledge of regulatory requirements and/or inspection trends
  • Ability to write and edit technical documentation
  • Ability to work and collaborate remotely

Requirements

  • Active PDA Membership
  • Time Commitment.
  • Most team meetings are held virtually with occasional opportunities for face to face discussions.
  • Term based: A Technical Report project is typically an 18 month to 2 year commitment

Deadline

Please send a CV highlighting your experiences that match this request not later than 30 November 2017.  If interested, please contact: Karena Grigsby, Volunteer Coordinator, volunteer@pda.org.

Technology Case Study

The PDA Letter is looking for authors to write short case studies based on their experiences implementing new technologies into their operations. These could be in manufacturing, labwork, packaging, etc. We’re looking for 750-1000 word articles. We’re always looking for such authors so there is no deadline. Authors can be of any background and level of experience.


Author or Contribute to the PDA Journal of Pharmaceutical Science and Technology

Manuscripts are accepted at any time and can include letters to the editor, commentaries, reviews, original research, and technology/applications (e.g., case studies).

Learn more about being a PDA Journal of Pharmaceutical Science and Technology Author.


Instructor for PDA Education Courses

PDA Education is looking for individuals who would like to teach either a lecture, hands-on or laboratory course on an innovative topic or a course in one of PDA's areas of specialty, including:

  • Aseptic Processing
  • Biotechnology
  • Combination Products
  • Environmental Monitoring
  • Filtration
  • Microbiology
  • Quality and Regulatory Affairs
  • Supply Chain
  • Training
  • Validation
  • Visual Inspection
If you are interested in teaching or have an idea for a new course, please send a cover letter and resume to Karena Grigsby, Volunteer Coordinator, PDA.