Courses

Navigating FDA 510(k) Submissions: How to Sidestep Common Mistakes and Ensure Approval

Learn From the Pros to Get it Right the First Time and Get Your Product to Market Faster!

Charles H. Paul

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

21 October 24 | Mon

Quality Risk Management: An In-Depth Guide to ICH Q9 (R1) for Safe and Effective Pharmaceutical Products

Ensure Safe, Compliant Pharmaceuticals With Proactive Risk Management Across the Product Lifecycle!

Meredith Crabtree

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

2 June 25 | Mon

Virtual Audits for FDA Compliance: A Must-Know Guide to Remote cGMP Inspections

Master Essential Virtual Audit Skills to Ensure FDA Compliance Remotely!

John E Lincoln

1 Hr. | 10 AM PT - 11 AM PT

30 May 25 | Fri

Quality Management 101: Optimizing Enterprise Maintenance with ISO Standards

Transform Maintenance With ISO 9001 Insights for Proactive, Quality-Driven Results!

John E Lincoln

1 Hr. | 10 AM PT - 11 AM PT

12 June 25 | Thu

Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards

Are FDA Approval Complexities and Multi-State IND Compliance Challenges Creating Critical Bottlenecks in Your Pipeline?

John E Lincoln

1 Hr. | 10 AM PT - 11 AM PT

29 May 25 | Thu

Cybersecurity Compliance For Medical Devices: Align With Latest FDA Standards

Protect Patient Data and Ensure Compliance in a Rapidly Evolving Landscape!

John E Lincoln

1 Hr. | 10 AM PT - 11 AM PT

12 June 25 | Thu

Stay Compliant with FDA’s New Draft on Software & Device Modifications: A 510(k) Update

Are You Certain Your Next Software or Device Update Won’t Require A New 510(k)?

Carolyn Troiano

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

4 June 25 | Wed

FDA Social Media Compliance 2025: Navigating Drug & Device Marketing Risks

Navigate New FDA Guidelines to Promote Safely, Responsibly, and Compliantly!

Carolyn Troiano

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

16 June 25 | Mon

FDA’s New 510(k) Standards: Stop Delays, Start Innovating Your Medical Devices

Stay Ahead Of The Curve With The FDA’s Modernized 510(k) Pathway!

John E Lincoln

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

7 May 25 | Wed

Masterclass: 3-Hour Intensive on Quality Management Systems (QMS) per ISO & US FDA’s GMPs

Struggling With Validation And Documentation? We’ve Got You Covered!

John E Lincoln

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

21 May 25 | Wed

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