Courses

What is Required for 21 CFR Part 11 Compliance?

Beyond Compliance: Perfecting 21 CFR Part 11 for FDA-Regulated Computer Systems

Future-Proof Your Compliance: Adapting to 21 CFR Part 11 in 2024!

Carolyn Troiano

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

DEC 05, 2024 (THU)

Process Validation Essentials

2025 FDA & ISO Process Validation Mastery: Advanced Process Validation for Global Regulatory Alignment

Stay Ahead or Pay the Price – Learn Cutting-Edge Strategies to Prevent Costly Compliance Mistakes!

Jose Mora

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

DEC 06, 2024 (FRI)

Project Management

Quality Planning in Medical Device Projects: A Comprehensive Training for Non-Project Managers

Transforming Medical Device Projects – The Power of Quality-Driven Project Management!

Charles H. Paul

90 Mins.| 10 AM PT - 11:30 AM PT | USD 209

DEC 06, 2024 (FRI)

FDA's New CSA Framework

FDA’s New CSA Framework: Simplifying Computer System Implementations and Ensuring Compliance

CSA vs. CSV—What You Need to Know for Easier Implementations!

Carolyn Troiano

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

DEC 06, 2024 (FRI)

What is Required for 21 CFR Part 11 Compliance?

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Future-Proof Your Compliance: Adapting to 21 CFR Part 11 in 2024!

Carolyn Troiano

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

DEC 06, 2024 (FRI)

Regulatory Documentation Gap Analysis

Conducting a Regulatory Documentation and Training Gap Analysis in the Life Sciences

Learn the entire process from start to finish about training materials and compliance documentation development.

Charles H. Paul

3 Hrs.| 10 am PT | USD 459

DEC 09, 2024 (MON)

Mastering QA and GMP

Mastering Modern Quality Assurance (QA) and Good Manufacturing Practice (GMP) in Drug Production: Elevate Your Manufacturing Excellence

Master the Essentials of Quality and Compliance in Pharma Manufacturing!

Charles H. Paul

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

DEC 09, 2024 (MON)

Computer System Validation (CSV) and FDA Compliance

Strategic Approach to Computer System Validation (CSV) and FDA Compliance

Critical Concepts of CSV and How to Apply Them in A New Technological Environment!

Carolyn Troiano

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

DEC 09, 2024 (MON)

COMPUTER SYSTEM VALIDATION BOOTCAMP

2-Day Virtual Boot Camp From Fundamentals to Advanced: Your Complete Guide to Computer System Validation (CSV) Mastery

Master CSV with Hands-On Techniques: 2-Day Boot Camp for Immediate Application!

Carolyn Troiano

12 Hrs.| 9 AM PT - 3 PM PT each day | USD 999

DEC 10 (TUE) - DEC 11 (WED), 2024

GMP Inspections

GxP Inspections Workshop – How to Prepare and What do Inspectors Look For?

Hope is Not a Practical Approach to Inspection Preparation. Identify Key Risks and Follow Expert Mitigation Strategies Prior to Your GMP Inspection.

Charles H. Paul

2 Hrs.| 10 am PT | USD 239

DEC 10, 2024 (TUE)

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