Online Compliance Training, FDA compliance training, Risk Management for medical device

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Industries

Drugs & Biologics

Medical Devices

SOX Compliance

HR Compliance

IT Compliance

OSHA Compliance

HealthCare Compliance

"Great webinar - Mr. Mukesh Kumar is a great speaker; it's clear he knows what he's talking about, gives practical advice and he presents well."

"I appreciated the speaker sharing the "hot topic" of acceptance activities. I would love to hear more "hot topics" along the way."

"I would just like to say thank you for your excellent webinar training and customer service."

"I really do believe this online compliance panel training has helped significantly to improve our standards."

"I've attended their webinar, I really experienced the brand quality and speakers did an excellent job."

"I wish they continue the same work and all the best for the future trainings."

"I'm extremely impressed with their topics which are predominately well."

On Demand Documents

510(k) Submission and Clearance

How to Survive a DEA Inspection Series Pharmacy Records and Security

Best Practices for Establishing a Compliant Medical Device and Complaint Handling System

How to Survive a DEA Inspection Series - For Manufacturers and Distributors

510(k) Submission Contents and Format for Medical Devices

Featured Trainings

Establish and Maintain an Effective Supplier Qualification Program

Instructor: David R Dills Live Session Monday, May 20, 2013 10:00 AM PDT | 01:00 PM EDT

Writing and Enforcing Effective SOPs

Instructor: David R Dills Live Session Tuesday, May 21, 2013 10:00 AM PDT | 01:00 PM EDT

Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)

Instructor: David Lim Live Session Wednesday, May 22, 2013 10:00 AM PDT | 01:00 PM EDT

Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality

Instructor: Mukesh Kumar Live Session Wednesday, May 22, 2013 10:00 AM PDT | 01:00 PM EDT

How to select Software for a Regulated Environment

Instructor: Angela Bazigos Live Session Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT

GMP Quality Principles

Instructor: Dr. James R Harris Live Session Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT

How to Manage a Product Medical Device Recall Efficiently and Effectively

Instructor: David R Dills Live Session Wednesday, May 29, 2013 10:00 AM PDT | 01:00 PM EDT

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Recorded Trainings

21 CFR Part 11 Complying with: Step by Step

Instructor: Chinmoy Roy Recorded Session Access recorded sessions unlimited viewing for 6 months.

The Infamous Form FDA 483: How you respond can make or break you

Instructor: Casper E Uldriks Recorded Session Access recorded sessions unlimited viewing for 6 months.

The Sunshine Act Reporting for Clinical Trials

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

Project Management for Computer Systems Validation

Instructor: Angela Bazigos Recorded Session Access recorded sessions unlimited viewing for 6 months.

FDA Inspection: Preparation and Management

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

Instructor: David R Dills Recorded Session Access recorded sessions unlimited viewing for 6 months.

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

Instructor: Jeff Schwegman Recorded Session Access recorded sessions unlimited viewing for 6 months.

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