FDA Regulatory, Quality and Compliance Seminars and Training

Recorded Seminars

Recorded Webinars

Aseptic Processing and Validation Practitioner Course – FDA Expectations and Industry Best Practices

Reclassification of Software Automated Medical Devices

📅 November 21, 2025 | 🕒 11 AM Eastern Time US | ⏳ 90 Minutes

Audit 101 - How to Conduct an Effective Audit & What They Don't Tell You May Happen

MEREDITH CRABTREE

📅 October 23, 2025 | 🕒 11 AM Eastern Time US | ⏳ 90 Minutes

FDA's Q-Submission Program for Medical Devices, SiMD / SaMD with Considerations for Using AI and ChatGPT

CAROLYN TROIANO

📅 October 15, 2025 | 🕒 11 AM Eastern Time US | ⏳ 90 Minutes

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

CHARLES H. PAUL

📅 December 09, 2025 | 🕒 11 AM Eastern Time US | ⏳ 60 Minutes

FDA Regulation For Over-The-Counter (OTC) Drug Products

MEREDITH CRABTREE

📅 November 24, 2025 | 🕒 11 AM Eastern Time US | ⏳ 90 Minutes

Test Product

CAROLYN TROIANO

📅 September 27, 2025 | 🕒 11 AM Eastern Time US | ⏳ 60 Minutes

Clinical Trial Risk Management - ICH E6(R3) and FDA Expectations

CHARLES H. PAUL

Duration: 60 Minutes

The Latest FDA Q-Submission Final Guidance

JOHN E. LINCOLN

Duration: 90 Minutes

Validation of FDA-Regulated Systems Used in Drug Development & Submissions Using Artificial Intelligence (AI), Machine Learning (ML) & Large Language Models (LLMs), such as ChatGPT

CAROLYN TROIANO

Duration: 90 Minutes

Pharmaceuticals