Drugs | Biologics | Food | Cosmetics | Dietary Supplements | Pharmacy Compounding | Devices | IVDs | Regulatory Affairs | Quality | Clinical Affairs | Regulatory Compliance | FDA Enforcement Matters

Medical Devices and IVDs

LIVE Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR) | Monthly, 2nd Wednesdays | 01:00 PM PST | 04:00 PM EST | Duration: 60 Minutes | Register Here
LIVE CE Mark: Content and Format for a Technical File and Design Dossier | Monthly, 2nd Tuesdays | 01:00 PM PST | 04:00 PM PST | Duration: 60 Minutes | Register Here
LIVE | Implementing Medical Device Complaint Handling Systems | Monthly, 2nd Thursdays | 11:00 AM PST | 02:00 PM EST | Duration: 60 Minutes | Register Here
LIVE | Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches | Monthly, 2nd Mondays | 11:00 AM PST | 02:00 PM EST | Duration: 60 Minutes | Register Here
LIVE Implementing Unique Device Identification Systems | Monthly, 2nd Thursdays | 11:00 AM PST | 02:00 PM EST | Duration: 60 Minutes | Register Here
LIVE | 510(k): Preparation, Submission, and Clearance | Monthly, 2nd Fridays | 11: 00 AM PST | 02:00 PM EST | 60 Minutes | Register Here
LIVE | Implementing Global Medical Device Adverse Event Reporting Systems in EU, Canada and US | Monthly, 2nd Wednesdays | 08: 00 AM PST | 11:00 AM EST | 60 Minutes | Register Here
LIVE | Developing and Implementing a Global Regulatory Plan and Strategy | Monthly, 2nd Fridays | 01: 00 PM PST | 04:00 PM EST | 60 Minutes | Register Here
LIVE | Understanding Corrections and CA-PA | Schedule a Date | 10: 00 AM PST | 01:00 PM EST | 90 Minutes | Click Here to Schedule a LIVE Online Seminar with Dan O’Leary
LIVE Best Practices for Communicating and Interacting with FDA Reviewers | Monthly, 2nd Thursdays | 08:00 AM PST | 11:00 AM EST | 60 Minutes | Register Here

FDA 510(k) Templates

FDA 510(k) Templates Ready for Use Compliant with eCopy and RTA Policy | Read More Here

LIVE Online Seminar Series

LIVE Online Seminar Series | Good Clinical Practice (GCP) | Register Here
LIVE Online Seminar Series | US FDA 510(k) Drafting | Register Here
LIVE Online Seminar Series | US FDA Premarket Approval (PMA) Drafting | Register Here
LIVE Online Seminar Series | Fundamentals of Regulatory Affairs for Drugs and Medical Devices | Register Here

Drugs

LIVE | Developing and Implementing a Global Regulatory Plan and Strategy | Monthly, 2nd Fridays | 01: 00 PM PST | 04:00 PM EST | 60 Minutes | Register Here
LIVE | Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU | Monthly, 2nd Mondays | 01: 00 PM PST | 04:00 PM EST | 60 Minutes | Register Here
LIVE | Quality Risk Management for Drugs and Biologics: Systematic and Holistic Approaches | Monthly, 2nd Mondays | 10:00 AM PST | 01:00 PM EST | 60 Minutes | Register Here
LIVE Online Seminar Series | Good Clinical Practice (GCP) | Read More Here

FDA Inspection Products

LIVEFDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers | Monthly, 2nd Mondays | 11:30 AM PST | 02:30 PM PST | 60 Minutes | Register Here
FDA Inspection Checklist to Avoid 483s for Drug Manufacturers | Learn More Here
FDA Inspection Checklist to Avoid 483s for Medical Device and IVD manufacturers | Read More Here

Share