Course Description:
Quality, with its checks and balances, is the foundation and a key to success for your pharma startup. A proactive, vigilant culture of quality is patient-focused and science-based, allowing you to identify and respond to issues while they are still small. It affects access and availability of medicines to support the commercialization of your product pipeline. Assuring quality becomes a competitive advantage as it creates higher yield, dependability, and sustainability to support your business needs.
A startup must build a culture of quality and set up consistent, reliable processes that deliver on objectives and promote continual improvement. This webinar outlines the most important aspects of quality management for a pharma startup, and how to set a foundation that builds toward a modern quality maturity model (QMM).
We will discuss areas of responsibility and accountability to prioritize patient-centricity and data accuracy and how to meet current and future regulatory requirements—right from the start.
- When to start building a quality unit
- Senior Management responsibilities
- Considerations for selecting quality employees
- Centralize vs. decentralize approaches to quality units
- Governance and oversight
- QMS approaches (paper vs. electronic)
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.
Though this course is being made available on USP’s
Education site, the course content was developed by Pharmatech Associates, a
USP company. USP has not independently reviewed or verified the accuracy
of the course content.
The live version of this recording took place on February 21, 2024
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
Stephanie Gaulding, CQA, CPGP
Managing Director, Pharmatech Associates – a USP company
M.Sc. biotechnology, Johns Hopkins University
B.Sc. biology, Virginia Tech