Courses

FDA Cybersecurity Compliance Bootcamp For Medical Devices: Safeguarding Patients And Data

Master The Latest FDA Protocols To Ensure Cybersecurity And Compliance!

Carolyn Troiano

6 Hrs. | 10:00 AM PT - 4:00 PM PT

6 May 25 | Tue

Mastering Root Cause Analysis, CAPA, and Effectiveness Checks: Practical Tools for Sustainable Solutions

Ensure Compliance And Drive Sustainable Quality With Proven RCA And CAPA Tools!

Meredith Crabtree

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

19 June 25 | Thu

Accelerate Your FDA 510(k) and PMA Submissions: A 3-Hour Virtual Seminar for Faster Approval

Are You Struggling with Delays and Setbacks in Your 510(k) or PMA Submissions?

Charles H. Paul

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

16 April 25 | Wed

Mastering GDPR Compliance: A Practical Guide For U.S. Professionals

Ensure Data Privacy And Avoid Costly GDPR Compliance Violations!

Justin Muscolino

1 Hr. | 10 AM PT - 11:00 AM PT

28 May 25 | Wed

6-Hour Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers

Safeguard Compliance And Minimize Risk With Proven Best Practices!

John E Lincoln

6 Hrs. | 9:00 AM PT - 3:00 PM PT

12 June 25 | Thu

Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements

Ensure Global Compliance With Bulletproof Data Integrity Practices!

Charles H. Paul

1 Hr. | 10 AM PT - 11:00 AM PT

12 June 25 | Thu

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files – The US FDA and EU MDR Requirements

Ensure Global Compliance With Expert Insights On Key Documentation!

John E Lincoln

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

11 June 25 | Wed

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

Ensure System Compliance Amid FDA’s Rapid Technology Transformation!

Carolyn Troiano

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

3 June 25 | Tue

Decoding FDA’s 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping

Ensure Audit-Ready Systems For FDA And EU Regulatory Inspections!

Charles H. Paul

1 Hr. | 10 AM PT - 11:00 AM PT

6 June 25 | Fri

Mastering Verification & Validation: Building a Compliant V&V Plan Aligned With FDA, ISO 13485 & ISO 14971

Ensure Regulatory Compliance With A Robust, Audit-Ready V&V Strategy!

John E Lincoln

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

11 June 25 | Wed

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