GLOBAL COMPLIANCE SEMINAR (GCS)

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

Seminar for the US RAC Examination Preparation (NEW)

LIVE |How to Most Effectively Prepare for the US RAC Exam | August 14, 2015 | 11: 00 AM PST | 02:00 PM EST | 90 Minutes | Register Here

Pharmaceutical Industry: Drugs and Compounding Pharmacy

LIVE | Developing and Implementing a Global Regulatory Plan and Strategy | Bi-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 | Tri-monthly, 2nd Mondays | 11: 00 AM PST | 02:00 PM EST | 60 Minutes | Register Here
LIVE | Quality Risk Management for Drugs and Biologics: Systematic and Holistic Approaches | Tri-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

 Medical Devices and IVDs

LIVE Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR) | Tri-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 | Bi-monthly, 2nd Thursdays | 01:00 PM PST | 04:00 PM EST | Duration: 60 Minutes | Register Here
LIVE | Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches | Bi-monthly, 1st Mondays | 01:00 PM PST | 04:00 PM EST | Duration: 60 Minutes | Register Here
LIVE Implementing Unique Device Identification (UDI) Systems | Tri-monthly, 2nd Tuesdays | 10:00 AM PST | 01:00 PM EST | Duration: 60 Minutes | Register Here
LIVE | FDA 510(k) Requirements: Best Practices | Tri-monthly, 3rd Thursdays | 12: 00 PM PST | 03:00 PM EST | 60 Minutes | Register Here
LIVE | Implementing Global Medical Device Adverse Event Reporting Systems in EU, Canada and US | Tri-monthly, 1st Mondays | 12: 00 PM PST | 03:00 PM EST | 60 Minutes | Register Here
LIVE | Developing and Implementing a Global Regulatory Plan and Strategy | Bi-monthly, 2nd Fridays | 01: 00 PM PST | 04:00 PM EST | 60 Minutes | Register Here
LIVE | Understanding Corrections and CA-PA | To Be Scheduled | 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 | Tri-monthly, 2nd Thursdays | 08:00 AM PST | 11:00 AM EST | 60 Minutes | Register Here
LIVE | Big Data in FDA-Regulated Healthcare Industry: Best Practices for Systematic Use | Tri-monthly, 2nd Thursdays | 10:00 AM PST | 01:00 PM EST | 60 Minutes | Register Here
LIVE | Complaint Handling and Medical Device Reporting (MDR) | Bi-monthly, 2nd Thursdays | 01:00 PM PST | 04:00 PM EST | Duration: 60 Minutes | Register Here
LIVE | FDA 510(k) Requirements: Best Practices | Monthly, 2nd Fridays | 11: 00 AM PST | 02:00 PM EST | 60 Minutes | Register Here
LIVE | FDA Pre-submission and 510(k): Best Practices | Monthly, 1st Wednesdays | 12: 00 PM PST | 03:00 PM EST | 60 Minutes | Register Here

Global Laws and Regulations for Medical Devices

LIVE | Medical Device Laws and Regulations in Asian Countries | Tri-monthly, 2nd Fridays | 08:00 AM PST | 11:00 AM EST | 60 Minutes | Register Here

Healthcare Industry: Social Media, Sales & Marketing | Big Data

LIVE | Good Social Media Practices to Avoid FDA Actions | Bi-monthly, 2nd Fridays | 09:00 AM PST | 12:00 PM EST | 60 Minutes | Register Here
LIVE Big Data in FDA-Regulated Healthcare Industry: Best Practices for Systematic Use | Tri-monthly, 3rd Mondays | 08:00 AM PST | 11:00 AM EST | 60 Minutes | Register Here

Healthcare Business Practices

Developing and Implementing an Effective SOP in Healthcare Industry | Tri-monthly, 4th Fridays | 11:00 AM PST | 02:00 PM EST | 60 Minutes | Read More Here

FDA Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Application Templates

Templates for PMA and HDE Applications| Read More 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) DraftingRegister Here
LIVE Online Seminar Series | US FDA Premarket Approval (PMA) DraftingRegister Here
LIVE Online Seminar Series | Fundamentals of Regulatory Affairs for Drugs and Medical Devices | Register | Here for Drugs or Here for Medical Devices

FDA Inspection Products for Drugs, Dietary Supplements, Biologics and Medical Devices

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

Online Seminars (Recorded)

RecordedCE Mark: Content and Format for a Technical File and Design Dossier | 60 Minutes | Read More Here
RecordedImplementing UDI systems | 60 Minutes | Read More Here
Recorded | US Laws and Regulations for Medical Devices including In Vitro Diagnostic Devices (IVDs) | 78 Minutes | Read More Here
Recorded | Complaint Handling and Medical Device Reporting (MDR) | 62 Minutes | Read More Here.  
RecordedRisk Management for Medical Devices and IVDs: Systematic and Holistic Approaches | 74 Minutes | Read More Here.
Recorded | 510(k) Drafting Seminar Series | 5 Sessions – 60 Min Per Session | Read More Here.
Recorded | PMA Drafting Seminar Series | 8 Sessions – 90 Min Per Session | Read More Here.
Recorded | How to Format Succinct and Comprehensive 510ks and PMAs | Two Days of Seminars | Read More Here.

Last Updated:  July 21, 2015

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