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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

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  • Live Training
 Establish and Maintain an Effective Supplier Qualification Program
Instructor: David R Dills
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Live Session Monday, May 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Writing and Enforcing Effective SOPs
Instructor: David R Dills
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done."
Live Session Tuesday, May 21, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)
Instructor: David Lim
This webinar is intended to discuss the requirements for medical device developers to meet the U.S. FDA's requirements on the 510(k).
Live Session Wednesday, May 22, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality
Instructor: Mukesh Kumar
Medical foods play an important role in the management of patients with special dietary restrictions and needs. The designation of medical food by FDA implies special handling, labeling, distribution and manufacturing requirements.
Live Session Wednesday, May 22, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
How to select Software for a Regulated Environment
Instructor: Angela Bazigos
Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.
Live Session Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT , Duration:120 $243.00
GMP Quality Principles
Instructor: Dr. James R Harris
We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing, Processing, Packing, or Holding of Drugs.
Live Session Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
How to Manage a Product Medical Device Recall Efficiently and Effectively
Instructor: David R Dills
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law.
Live Session Wednesday, May 29, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Risk Assessment
Instructor: Harry Huss
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. Even if one is not involved in doing the Risk Management, it would not hurt for them to understand something of what it is in case they observe something going wrong during the research.
Live Session Tuesday, June 4, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Instructor: David R Dills
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only apply to unapproved devices.
Live Session Thursday, June 6, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
Instructor: Mukesh Kumar
The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.
Live Session Tuesday, June 11, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Business Continuity & Disaster Recovery
Instructor: Harry Huss
This is a course that anyone in a Pharmaceutical Company, CRO, hospital or clinic involved in clinical research should take.
Live Session Tuesday, June 18, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
CE Marking: MDD, AIMDD and IVDD
Instructor: David Lim
This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices.
Live Session Wednesday, June 19, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Hosting for Regulatory Inspections
Instructor: Harry Huss
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. If they have never been involved they will learn what one is, if they have done clinical trials it will be useful to put everyone on the same level as far as terms and operations.
Live Session Wednesday, July 10, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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