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.
Who Should Attend:
- 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.