Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Speaker: Jose Mora
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90308

Mon
17
Jun 2019

$189

Register

Verification or Validation of Methods in Food Microbiology (+)
Verification or Validation of Methods in Food Microbiology (+)

Speaker: Michael Brodsky
Time:11:00 AM PST | 02:00 PM EST
Duration:60 Minutes
Model : GRC-90615

Tue
21
May 2019

$189

Register

Stunning Changes in FDA's Software Regulation (+)
Stunning Changes in FDA's Software Regulation (+)

Speaker: Casper Uldriks
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90610

Thu
16
May 2019

$169

Register

Root Cause Analysis and CAPA (+)
Root Cause Analysis and CAPA (+)

Speaker: Susanne Manz
Time:10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Model : GRC-90606

Tue
14
May 2019

$169

Register

Writing and Enforcing Effective SOPs
Writing and Enforcing Effective SOPs

Speaker: David R. Dills
Time:10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Model : GRC-90612

Thu
02
May 2019

$189

Register

Medical Device Recalls – A Complete Prevention Strategy
Medical Device Recalls – A Complete Prevention Strategy

Speaker: Charles H. Paul
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90616

Thu
25
Apr 2019

$169

Register

21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR
21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

Speaker: David Nettleton
Time:10:00 AM PST | 01:00 PM EST
Duration:70 Minutes
Model : GRC-90566

Thu
25
Apr 2019

$169

Register

Risk-based Design Control - The New Paradigm for Medical Device Design
Risk-based Design Control - The New Paradigm for Medical Device Design

Speaker: Jose Mora
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90617

Wed
24
Apr 2019

$169

Register

Measurement Uncertainty in Microbiology (+)
Measurement Uncertainty in Microbiology (+)

Speaker: Michael Brodsky
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90580

Thu
18
Apr 2019

$189

Register

Validation and Control of Excel Spreadsheets in Regulated Environments (R)
Validation and Control of Excel Spreadsheets in Regulated Environments (R)

Speaker: Ludwig Huber
Time:10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Model : GRC-90438

Thu
18
Apr 2019

$189

Register

FDA Pre-Submission process, IDE, 510(k), PMA and IVD - (+)
FDA Pre-Submission process, IDE, 510(k), PMA and IVD - (+)

Speaker: Grace Powers
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90614

Wed
17
Apr 2019

$169

Register

FDA Regulations of OTC Drugs in the U.S
FDA Regulations of OTC Drugs in the U.S

Speaker: NORMA SKOLNIK
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90592

Tue
16
Apr 2019

$169

Register

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)
How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

Speaker: Dr. David Lim
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90593

Mon
15
Apr 2019

$169

Register

Essentials of Validation – IQ, OQ and PQ Protocols
Essentials of Validation – IQ, OQ and PQ Protocols

Speaker: Susanne Manz
Time:10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Model : GRC-90578

Wed
10
Apr 2019

$169

Register

Quality Control for Microbiological Media and Reagents
Quality Control for Microbiological Media and Reagents

Speaker: Michael Brodsky
Time:09:00 AM PST | 12:00 PM EST
Duration:60 Minutes
Model : GRC-90581

Wed
10
Apr 2019

$169

Register

Fishbone Diagramming (+)
Fishbone Diagramming (+)

Speaker: Dr. Michael Abitz
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90571

Wed
03
Apr 2019

$189

Register

Food Recall Management
Food Recall Management

Speaker: Michael Brodsky
Time:09:00 AM PST | 12:00 PM EST
Duration:60 Minutes
Model : GRC-90541

Fri
29
Mar 2019

$189

Register

FDA - Social Media Advertising - What are the FDA Interpretations & Expectations (+)
FDA - Social Media Advertising - What are the FDA Interpretations & Expectations (+)

Speaker: Casper Uldriks
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90584

Tue
26
Mar 2019

$189

Register

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Speaker: Jose Mora
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90568

Mon
25
Mar 2019

$169

Register

How to Conduct a Human Factors/ Usability Validation
How to Conduct a Human Factors/ Usability Validation

Speaker: Edwin Waldbusser
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90549

Fri
22
Mar 2019

$189

Register

FDA PMA (PreMarket Approval)
FDA PMA (PreMarket Approval)

Speaker: Grace Powers
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-NR22

Sat
16
Mar 2019

$429

Register

510(K) Submission - A Comprehensive and an Updated Overview
510(K) Submission - A Comprehensive and an Updated Overview

Speaker: Dr. David Lim
Time:10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Model : GRC-90558

Thu
07
Mar 2019

$229

Register

Qualification of Contract Manufacturer Organizations Based on Practical Experience
Qualification of Contract Manufacturer Organizations Based on Practical Experience

Speaker: Edwin Waldbusser
Time:10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Model : GRC-90575

Thu
07
Mar 2019

$229

Register

Comparing GLP with GMP
Comparing GLP with GMP

Speaker: Ludwig Huber
Time:10:00 AM PST | 01:00 PM EST
Duration:70 Minutes
Model : GRC-90510

Tue
05
Mar 2019

$229

Register

Complaint Handling and Medical Device Reporting
Complaint Handling and Medical Device Reporting

Speaker: Susanne Manz
Time:10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Model : GRC-90576

Fri
01
Mar 2019

$189

Register

Understanding the US FDA Drug Review and Approval Process
Understanding the US FDA Drug Review and Approval Process

Speaker: Dr. David Lim
Time:10:00 AM PST | 01:00 PM EST
Duration:70 Minutes
Model : GRC-90540

Wed
13
Feb 2019

$209

Register

How to prepare for and host a FDA inspection and respond to 483’s
How to prepare for and host a FDA inspection and respond to 483’s

Speaker: Edwin Waldbusser
Time:10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Model : GRC-90504

Mon
17
Dec 2018

$229

Register

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program
How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Speaker: Ludwig Huber
Time:10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Model : GRC-90511

Wed
05
Dec 2018

$245

Register

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

Speaker: Kelly Eisenhardt
Time:10:30 AM PST | 01:30 PM EST
Duration:60 Minutes
Model : GRC-NR11

Tue
04
Dec 2018

$425

Register

Implementing a (UDI) Unique Device Identification System
Implementing a (UDI) Unique Device Identification System

Speaker: Dr. David Lim
Time:10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Model : GRC-90496

Thu
15
Nov 2018

$259

Register