Courses

Navigating Clinical Trials: Mastering TMF/eTMF & Meeting FDA Requirements

Are You Confident in Your TMF’s Audit Readiness?

Carolyn Troiano

90 Mins. | 10 AM PT - 11:30 AM PT

20 May 25 | Tue

Mastering Lean Document Systems for Life Sciences: Building a Compliant, Efficient Controlled Document System to Meet FDA Standards

Learn How to Optimize Your Document Management Using Lean Configuration Principles and Minimize Errors!

Jose Mora

90 Mins. | 10 AM PT - 11:30 AM PT

27 May 25 | Tue

The Future of Pharmaceutical Clean Rooms: Innovating Environmental Monitoring for 2024 and Beyond

Stay Compliant And Ahead With Cutting-Edge Monitoring Solutions for 2024-25!

Roger Cowan

90 Mins. | 10 AM PT - 11:30 AM PT

17 June 25 | Tue

4-Part Series to Achieve Error-Free Compliance: Master Human Error Prevention & GMP Excellence in 2024

Walk Away with Practical, High-impact Tools to Avoid Unexpected Compliance Setbacks!

Ginette Collazo

6 Hrs. | 10 AM PT - 11:30 AM PT

12 May 25 | Mon

Risk Management for Medical Devices: Complying with ISO 14971:2019 and FDA Latest Requirements

Ensure Your ISO 14971 Compliance Evolves With Your Device Innovations And Unseen Risks Of Tomorrow’s Technologies!

Jose Mora

90 Mins. | 10 AM PT - 11:30 AM PT

22 May 25 | Thu

2-Day Virtual Boot Camp on 2024 FDA Compliance & Digital Clinical Trials: Mastering Computer System Validation

Outdated Validation Strategies Could Leave You Vulnerable to The Unpredictable!

Carolyn Troiano

12 Hrs. | 8 AM PT - 2 PM PT each day

19 June 25 | Thu

Harnessing ChatGPT & AI for Regulatory Project Management in FDA-Regulated Industries

Mitigate Risks and Enhance Compliance Using AI-driven Project Management Strategies!

Charles H. Paul

90 Mins. | 11 AM PT - 12:30 PM PT

2 May 25 | Fri

6-Hour Virtual Bootcamp on Shielding Your Medical Device Data: Proven Strategies to Outsmart Cyber Threats and Ensure FDA Compliance

Implement Advanced Risk Management, Develop A Robust SQA Plan, & Stay Ahead of Emerging Cybersecurity Threats!

Carolyn Troiano

6 Hrs. | 9 AM PT - 3 PM PT

9 June 25 | Mon

21 CFR Part 11 Made Easy: Ensure Compliance Across Computerized Systems

Learn from the Expert: Master 21 CFR Part 11 Compliance and Actionable Strategies in 3 Hours!

Carolyn Troiano

3 Hrs. | 10:00 AM PT - 1:00 PM PT

19 June 25 | Thu

Mastering Test Method Validation (TMV) for Medical Devices: Ensuring Compliance and Performance

Is Your TMV Protecting Against Hidden Compliance Pitfalls?

Jose Mora

90 Mins. | 10 AM PT - 11:30 AM PT

14 May 25 | Wed

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