Outsourcing Fundamentals STREAM

  1. Managing Multiple Partners – And Materials – From Around The Globe 10/24/2023

    Two development and manufacturing outsourcing professionals – one based in Australia and one the east coast of the U.S. – begin our discussion on global outsourcing.

  2. Start With An Integrated, Verified PFS System 5/21/2026

    Synchrony S1 PFS system delivers an integrated, verified solution designed to streamline submissions, support reliable supply, and reduce development risk.

  3. Accountability For The Whole PFS System 5/21/2026

    When component suppliers only own their part, system-level performance becomes your responsibility. And if something fails, accountability disappears into the gaps.

  4. Annex 1 FAQs: Responding To The 2022 Revision 5/11/2026

    Viewing the Annex 1 revision as a natural extension of current habits, rather than a burden, allowed for a seamless transition. Since contamination control was already standard, the update simply validated existing excellence.

  5. Selecting A CDMO: A Guide To Successful Collaboration 5/21/2025

    Join Dr. Srinivasan Shanmugam in this webinar to learn key strategies for selecting the right CDMO, reducing costs, accelerating timelines, and ensuring product success.

  6. Planning For Scale-Up 5/21/2026

    From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.

  7. Annex 1 FAQs: How Do You Understand Risk Regarding Contamination Control? 5/11/2026

    True Annex 1 compliance requires a facility-wide contamination-control culture. Discover how rigorous risk awareness shapes behavior at every touchpoint across a manufacturing environment.

  8. Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1? 5/11/2026

    Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.

  9. Annex 1 FAQs: How Are We Responding To Foster Trust With Customers? 5/11/2026

    When regulations evolve, your suppliers’ ability to adapt shapes your ability to deliver. Learn how stronger manufacturing, quality, and personnel standards combined with radical transparency make compliance an advantage.

  10. Annex 1 FAQs: How Are We Responding To Provide Confidence For Customers? 5/11/2026

    For procurement and quality teams evaluating packaging and delivery component suppliers, understanding how a partner responds to regulatory change matters as much as the quality of their products.