Leveraging Existing Clinical Data for Extrapolation To Pediatric Uses Of...
In the draft guidance, the FDA focuses its attention on the opportunity to leverage existing clinical data (adult and/or non-pediatric data) for use in pediatric indications. By leveraging the data,...
View ArticleeCTD: How Will It Affect Your Promotional Submissions?
Last month, the industry got their hands on a highly anticipated draft FDA guidance discussing the submission of promotional materials using the Electronic Common Technical Document (eCTD). However,...
View ArticleDevice Quality Audits – Your Best Defense Against A FDA 483
Date: Wednesday, June 3, 2015 Time:1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299
View ArticleCan Better Relationships Improve Clinical Trials?
A classic problem in clinical research has been patient awareness. That is one reason why the industry has turned to advertising to get the message about trials out to the patients. But that does not...
View ArticleProject Management: Best Practices for Validation & Regulatory Projects
Date: Wednesday, August 5, 2015 Time: RECORDED VERSION Duration: 90 Minutes - Online Price:$299 - Includes Bonus Handouts!
View ArticleCloud Computing In A GxP Environment: Three Key Success Factors
Date: Thursday, August 13, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price:$299 - Includes Bonus Handouts!
View Article21 CFR Part 11: Understanding the ERES Regulation for Compliance Success
Date: August 25, 2015 Time: RECORDED VERSION Duration: 90 Minutes Price: $299 - Includes Bonus Handouts!
View ArticlePricing Human Lives…And The Drugs That Save Them
As professionals in the pharma industry, we often face questions regarding the high price of medicines and the greed of the companies producing them. Some items are easy to put a price on. Most of the...
View ArticleNew Pharma Compliant Google Ad Formats – Implementation Tips For Success
Date: Tuesday, August 4, 2015 Time: RECORDED VERSION Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!
View ArticleHuman Error: What Pharma Should Know And Do About It — Part One
When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science...
View ArticleHow to Prepare for an FDA Inspection of Medical Devices
Date: Wednesday, September 23, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!
View ArticleCE Marking of Medical Devices – A Step-by-Step Guide for Compliance
Date: Thursday, October 15, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price:$299 - Includes Bonus Handouts!
View ArticleHuman Error: What Pharma Should Know And Do About It — Part Two
When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science...
View ArticleHuman Error: What Pharma Should Know And Do About It — Part Three
When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science...
View ArticleHuman Error: What Pharma Should Know And Do About It — Part Four
When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science...
View ArticleSurviving A FDA Good Laboratory Practices (GLP) Inspection – Critical Tips...
Date: Thursday, September 24, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!
View ArticleFDA Quality Metrics Draft Guidance: What You Need to Know to be Prepared for...
Date: Thursday, September 17, 2015 Time:1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!
View ArticleFDA's New Final Guidance On Method Development And Validation – What You Must...
Date: Tuesday,September 29, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299 - Introductory Rate
View ArticleEffective Validation Master Planning: Key Steps for Success
Date: October 7, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes Price: $299 - Includes Bonus Handouts!
View ArticleSingle-Use Disposable Process Technologies - Best Practices And Advantages
Date: October 22, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!
View Article