Date: Dec 3, 11:30 AM EST
Description
In industries like pharmaceuticals, biotechnology, and medical devices, adhering to GxP regulations is critical for ensuring product quality, safety, and efficacy. This roundtable webinar will delve into the intricacies of GxP compliance within the context of project management. Expert panelists will share insights and best practices for successfully managing projects while meeting stringent regulatory requirements.In industries like pharmaceuticals, biotechnology, and medical devices, adhering to GxP regulations is critical for ensuring product quality, safety, and efficacy. This roundtable webinar will delve into the intricacies of GxP compliance within the context of project management. Expert panelists will share insights and best practices for successfully managing projects while meeting stringent regulatory requirements.
Key Discussion Points:
- GxP Fundamentals for Project Managers: What are the core principles of GxP (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, etc.) and how do they apply to project management activities?
- Risk Management and GxP Compliance: How can project managers identify, assess, and mitigate risks related to GxP compliance throughout the project lifecycle?
- Documentation and Record-Keeping: What are the essential documentation and record-keeping practices required for GxP compliance in project management? How can electronic systems and tools be leveraged effectively?
- Validation and Qualification in GxP Projects: How can project managers ensure that systems, processes, and equipment used in GxP projects are properly validated and qualified?
- Training and Competency: What are the training and competency requirements for project teams working on GxP regulated projects?
- Inspection Readiness: How can project managers prepare for and manage regulatory inspections effectively?
Case Studies and Lessons Learned: Real-world examples of successful GxP compliant projects and lessons learned from common challenges.
- Project managers in regulated industries (pharmaceuticals, biotechnology, medical devices)
- Quality assurance professionals
- Regulatory affairs professionals
- Validation specialists
- Anyone involved in managing projects that require GxP compliance
- Gain a comprehensive understanding of GxP requirements in project management.
- Learn practical strategies for integrating GxP compliance into project planning, execution, and monitoring.
- Discover best practices for documentation, validation, and inspection readiness.
- Network with industry experts and peers facing similar challenges.
Nira Mahesh, MA
Nira Mahesh, MA is a seasoned executive with over 18 years experience in operational leadership, product development, and strategic program management. Combining her foundation as a quality-minded bench scientist, with her PMP, CSPO, and CSM certifications, she’s transformed global team dynamics and driven business outcomes in the Healthcare IT and Digital Health innovation spaces. She is currently the Founder of Illuminira Consulting, a boutique Management Consulting Firm based outside of Boston, MA
Danielle Devereaux, MBA
Danielle Devereaux, MBA is a versatile consultant with Kalleid since 2020, specializing in project management, change management, and content development. Her background in electrical and computer engineering, coupled with an MBA and Agile expertise, enables her to effectively deliver and support software solutions across diverse industries.
Shannon Browne, MS, MBA
Shannon Browne, MS, MBA is a senior program management consultant at Kalleid Consulting. With a background as a bench scientist in neuroscience and experience as a business manager for a global pharmaceutical research unit, Shannon brings deep expertise in project management for R&D-facing projects at leading pharmaceutical companies.