Info Sheet: Extending Your Quality Capabilities

By |2022-08-18T13:38:34-04:0008/18/2022|

PDF Available > Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced treatments. Converge Consulting understands the complexities and [...]

Transitioning to Computer Software Assurance from Computer Systems Validation

By |2022-03-29T09:57:35-04:0003/29/2022|

Transitioning to Computer Software Assurance from Computer Systems Validation Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional approach for meeting this requirement is computer system validation (CSV). CSV emerged decades ago when computer systems were less reliable, and software was [...]

CMC Project Plans: A Critical Tool for Early-Stage Biopharma

By |2022-01-25T10:42:30-05:0001/25/2022|

CMC Project Plans: A Critical Tool for Early-Stage Biopharma The Challenge for CMC Teams CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team achieving milestones, which are technical and cross-functional. They also typically require capital investments. CMC teams operate in [...]

Info Sheet: Clinical Supply Chain Services

By |2022-11-17T11:33:56-05:0011/09/2021|

PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]

Personal Information Protection: Broader than You Think

By |2021-11-02T10:12:07-04:0011/02/2021|

National and state governments are enacting laws to protect personal identifiable information (PII) from use without data subjects’ consent. Additionally, federal regulations are now in place to safeguard protected health information (PHI). A few examples of such laws active today are the General Data Protection Regulation by the European Union, the California Consumer Privacy [...]

Info Sheet: Cell & Gene Therapy Services

By |2022-04-13T15:13:00-04:0003/02/2021|

PDF Available > Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and gene therapies (CGT) requires rethinking traditional business models [...]

Inaugural Meeting of the Supply Chain Working Group

By |2021-03-26T10:56:22-04:0011/19/2020|

December 17, 2020 @ 12:00 – 1:00p Join the Supply Chain Working Group Sign up as a member of the Life Sciences Supply Chain Working Group by registering for this inaugural event. The group currently has over 30 members who are supply chain executives at the Director level or above. The meeting program [...]

Event Recap: Stage-Appropriate Quality Systems

By |2022-11-08T14:39:17-05:0010/22/2020|

Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]

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