FDA Regulatory, Quality and Compliance Seminars and Training

Recorded Seminars

Recorded Webinars

Developing Effective Post Market Surveillance and Complaint Handling Requirements (Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls)

JOHN E. LINCOLN

December 10 - 11, 2024 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

Good Manufacturing Practices (GMP) 101

MICHAEL ESPOSITO

November 18 - 19, 2024 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

eCTD Submissions - Fundamentals and Process

CHARLES H. PAUL

Duration: 90 Minutes

Design of Experiments 101 - Methods and Analysis

ELAINE EISENBEISZ

October 28 - 29, 2024 | US Eastern Time: 11 AM to 5 PM | Central Europe Time: 5 PM to 11 PM

Design Verification and Validation

Duration: 90 Minutes

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

Duration: 90 Minutes

Calculations for Process and Product Capability

ELAINE EISENBEISZ

Duration: 90 Minutes

Laboratory Developed Tests (LDT) - The Impact of the Final Rule

JOHN E. LINCOLN

Duration: 90 Minutes

Cybersecurity in Medical Devices Latest Guidance: Quality System Considerations and Content of Premarket Submissions

CAROLYN TROIANO

Duration: 90 Minutes

Nitrosamines Impurities Management

Duration: 2 Hour

Pharmaceuticals