Courses

FDA INSPECTIONS

FDA Inspections: Applying Risk Assessment to Achieve Compliance

Avoid a Long Term Negative Relationship with FDA by Having A Plan and Implementing It!

John Misock

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

APR 21, 2025 (MON)

FDA Warning Letters

FDA Warnings : What Prompt FDA to Issue Letters & How to Avoid Them?

Master Framework of GxP/GMP Regulations, QMS, Quality Audit and How to Successfully Pass any Quality Audit!

Eleonora Babayants

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

APR 21, 2025 (MON)

Developing Conflict Competent Leaders

Leading Through Fire: Can Your Leaders Tame Conflicts with Finesse?

Say Goodbye to Workplace Friction: Learn the Art of Conflict Management!

Bob Churilla

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

APR 21, 2025 (MON)

Risk Based IT Qualification

Risk-Based IT Infrastructure Qualification & Compliance: Best Practices & Controls

Gain Insights Into Best Practices for Handling FDA Audits and Maintaining Compliance in IT Infrastructure!

Carolyn Troiano

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

APR 21, 2025 (MON)

MEDICAL DEVICE CYBERSECURITY FDA COMPLIANCE

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 | USD 759

APR 21, 2025 (MON)

FDA Compliance

How to Comply with the FDA’s Quality System Regulation (QSR) – 21 CFR Part 820

Build Your Thorough Understanding of The Regulation to Ensure You are Compliant to It.

Charles H. Paul

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

APR 22, 2025 (TUE)

What is Required for 21 CFR Part 11 Compliance?

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA: Compliance Chaos or Crystal Clarity? A 6-Hour Deep Dive

Avoid FDA Enforcement Action: Unlock the 2024 Roadmap to Compliance Before It’s Too Late!

Carolyn Troiano

6 Hrs.| 08 AM PT - 02 PM PT | USD 759

APR 22, 2025 (TUE)

MEDIATION SKILLS FOR LEADERS

Why Aren’t Your Team Members Speaking Up – Mediation Skills To Turn Resistance into Cooperation

Avoid The Drawbacks of Traditional Conflict Resolution & Create Lasting Solutions!

Ben Adkins

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

APR 22, 2025 (TUE)

Excuse Makers handling

Difficult Employees Sabotage and Obstruct Work Projects: How to Transform Excuse Makers into Accountable Leaders

Strategies for Dealing with Different Types of Difficult Employees at Work!

Bob Churilla

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

APR 22, 2025 (TUE)

Computer System Validation

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer System

Master A Risk-based, Product Quality, and Patient-Centric Approach to Computer System Assurance (CSA)!

Carolyn Troiano

90 Mins.| 10 am PT | USD 189

APR 22, 2025 (TUE)

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