Courses

Master 21CFR 820 & ISO 13485 in 2024!

Mastering Medical Device Quality Bootcamp: Integrating and Excelling with 21CFR 820 & ISO 13485 in 2024

Empowering Excellence in Quality Compliance: Your Gateway to 2024’s Medical Device Standards!

Charles H. Paul

4 Hrs.| 9 AM - 1:00 PM PT | USD 559

DEC 02, 2024 (MON)

21 CFR Part 11 Simplified

Cut Through the Complexity: Simplify 21 CFR Part 11 Compliance for Seamless Computer System Validation

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

Carolyn Troiano

3 Hrs.| 9 AM PT - 12 PM PT | USD 459

DEC 02, 2024 (MON)

MEDICAL DEVICE CYBERSECURITY FDA COMPLIANCE

Cybersecurity Compliance: Master the Latest FDA Guidelines for Medical Devices

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

John E Lincoln

1 Hr.| 10 AM PT - 11 AM PT | USD 229

DEC 03, 2024 (TUE)

FDA 510 k Submission Process

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 | USD 229

DEC 03, 2024 (TUE)

Excel spreadsheet validation

How to Stop Spreadsheet Nightmares: Master Risk-Based Validation of Spreadsheet Applications

Elevate Your Expertise: Streamline Validation, Secure Data, and Excel in Compliance!

Carolyn Troiano

3 Hrs.| 9 AM PT - 12 PM PT | USD 459

DEC 03, 2024 (TUE)

COMPUTER SYSTEM VALIDATION BOOTCAMP

3-Day Virtual Boot Camp on Mastering Computer System Validation (CSV) – Your Path to CSV Mastery!

Overwhelmed by Latest CSV Demands? How About a 3-Day Roadmap to Clarity?

Carolyn Troiano

12 Hrs.| 9 AM PT - 1 PM PT each day | USD 999

DEC. 03 (TUE) - DEC. 05 (THU), 2024

Drug Manufacturing Standards

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 | USD 229

DEC 04, 2024 (WED)

CAPA

CAPA Under the FDA Lens: Why Do CAPA Systems Fail, and How Can You Ensure Yours Doesn’t?

Learn from Real CAPA Failures and Master CAPA Best Practices to Satisfy FDA Expectations!

Charles H. Paul

90 Mins.| 10 AM PT - 11:30 AM PT | USD 229

DEC 04, 2024 (WED)

Data Integrity and Privacy

Data Integrity & FDA Governance: Modern Strategies for Regulated Computer Systems

Empower Your Compliance: Proactive Strategies for System Integrity & Compliance!

Carolyn Troiano

90 Mins.| 10 AM PT - 11:30 AM PT | USD 229

DEC 04, 2024 (WED)

Quality Management 101

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 | USD 229

DEC 05, 2024 (THU)

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