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Parenteral Drug Association Connecting People, Science and Regulation ®

Upcoming Volunteer Opportunities

PDA Connect Community Leader: Management of Outsourced Operations

Management of Outsourced Operations Interest Group looking for a new leader

Mission Statement

The Management on Outsourced Operations Interest Group will provide a platform for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities, and, serve as the liaison between RAQAB and follow-up of the PCMO Task Force.

Scope

  • To monitor regulatory developments, guidance’s and standpoints regarding management of outsourced activities
  • To support the preparation of position papers, Points to Consider documents, or a Technical Report on outsourcing as well as submission of articles to the PDA Letter; which may evolve from IG Meetings
  • To proactively identify ways of ensuring a global approach for integration of ICH Q10 using ICH Q9, and principles of Quality Risk Management in managing outsourced activities
  • To provide input to scheduling and content of PDA conferences and TRI courses on outsourcing.

The IG leader role is an important connection to PDA members at large. IG leaders are expected to keep abreast of developments in the IG area of interest and to promote frequent interaction with their membership. PDA Connect is an excellent tool for accomplishing this. IG Leaders also have networking opportunities with Regulatory and Quality Advisory Board (RAQAB) Members and other IG leaders as well as opportunities to host F2F meetings during PDA signature conferences. The ideal candidate will have experience or current job function working with outsourcing partners or in a CMO/CDO.

Requirements

  • Active PDA Membership Required
  • Residing in the United States (optional)

Time Commitment

  • Long-term volunteer opportunity: 3 years
  • The anticipated time commitment is about 15 minutes per day.

Please send a CV highlighting your experience that match this request to Karena Grigsby, Volunteer Coordinator, volunteer@pda.org.

Please note: If selected for this position, you will receive online community management training, and you will join a forum with PDA's other community coordinators where you can learn from each other’s' experience and brainstorm together.


Quality Systems Interest Group - Continued Process Verification (CPV) Task Force

Quality Systems Interest GroupThe European branch of the Quality Systems Interest Group is looking for volunteers to help develop an introduction to CPV (Continued Process Verification), the 3rd stage of process validation and establish a connection to the topic 'Quality Systems'. The topics of SPC (Statistical Process Control) and APR / PQR should be addressed. Present the key elements of CPV and best practices for CPV process implementation.

Experience/Skills in the following

  • Process monitoring of Critical Quality Attribute (CQA)
  • Critical Process Parameter (CPP)
  • Statistical Process Control (SPC)
  • Out of Trend (OOT)
  • And/or Process Validation

Requirements

  • Active PDA Membership Required
  • Time Commitment: team meetings are held virtually with occasion opportunities for face to face discussions (Occasional 1x or 2x per year. F2F meetings but not required).

Deadline

Please send a CV highlighting your experience that match this request no later than 29 June 2018. 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.