Agile project management is widely recognized for its ability to accelerate delivery, improve cross-functional visibility, and promote rapid problem solving-capabilities that have become increasingly valuable in the highly regulated GMP and GCP environments of the life-sciences industry.
This webinar provides a practical, compliance-centered exploration of how Agile principles can be successfully applied to pharmaceutical, biotech, medical device, and clinical research projects without compromising regulatory expectations or documentation rigor. Participants learn how Agile can be adapted to meet the stringent requirements of FDA, EMA, and global regulatory frameworks while still offering the flexibility and speed that teams need to navigate modern development and quality challenges.
The session begins by examining the feasibility of Agile within GxP functions. While pure Agile emphasizes adaptability, evolving requirements, and lightweight documentation, regulated environments demand traceability, pre-defined requirements, approval workflows, evidence-based documentation, and audit-ready records. This webinar clarifies where Agile aligns naturally with these needs-such as iterative risk management, incremental verification, early quality engagement, and improved communication-and also where it does not. Through this lens, participants gain a realistic understanding of how to modify Agile practices to ensure compliance. The presentation discusses core Agile elements including sprints, backlogs, user stories, acceptance criteria, and ceremonies, emphasizing how each can be tailored to support design controls, validation protocols, clinical requirements, and quality system expectations.
A major focus of the training is how to integrate Agile processes into regulatory frameworks like 21 CFR Parts 210/211/820, ICH E6(R2/R3), ICH Q9, and ICH Q10. Participants learn how to maintain audit trails, produce compliant documentation, and ensure traceability across iterative development cycles. Realistic strategies are presented for mapping Agile artifacts to required regulatory deliverables, such as linking user stories to user requirements, acceptance criteria to verification steps, sprint outcomes to Design History File elements, and sprint retrospectives to continuous improvement activities. The session also explores which digital tools (e.g., JIRA, Azure DevOps, eQMS platforms) can be used in GxP projects, along with configuration considerations to maintain compliance with data integrity standards.
Because most GMP and GCP organizations cannot adopt Agile in its pure form, the webinar introduces several hybrid models that combine the structure of Waterfall with the adaptability of Agile. These include stage-gate models, hybrid documentation strategies, and approaches where foundational requirements and initial risk assessments are completed upfront, while iterative development and verification occur in short cycles. This hybrid approach is often the most feasible way to meet regulatory expectations while delivering work more efficiently. Attendees learn how hybrid governance models support design controls, validation plans, change control, CAPA workflows, and clinical operations without losing the responsiveness that Agile provides.
By the conclusion of this program, participants will understand not only how Agile can be implemented in a compliant manner, but also how to evaluate feasibility, overcome common cultural and procedural barriers, and create a practical project management framework that balances regulatory discipline with modern execution efficiency. This session equips regulated-industry professionals with a realistic, actionable roadmap for adopting Agile or hybrid Agile methods that enhance project success while protecting quality and compliance.
Why should you Attend:
Participants should attend this webinar because Agile project management is rapidly becoming a competitive advantage in regulated life-sciences environments-yet many organizations still struggle to apply Agile effectively without jeopardizing GMP or GCP compliance. This session provides the practical, compliance-focused guidance that teams need to modernize their project execution approach while still meeting FDA, EMA, and ICH expectations for documentation, traceability, validation, and risk management.
The webinar demystifies Agile for regulated teams by showing exactly how Agile can be adapted-not blindly adopted-to fit the structured world of quality systems, manufacturing operations, clinical research, and validation. Attendees learn where Agile works well, where it does not, and how hybrid models can bridge the gap when a pure Agile approach is not feasible. This ensures participants walk away with realistic, actionable strategies rather than idealized theory.
By learning how to align Agile workflows with design controls, change control, audit readiness, and data integrity requirements, participants gain tools to accelerate project delivery, reduce rework, improve cross-functional communication, and manage risks earlier and more effectively. Anyone seeking to boost project efficiency and compliance simultaneously will benefit directly from this training.
Areas Covered in the Session:
