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Best Practices in CMC Dossier Preparation – Facing Tough Challenges

Date: Friday, October 16, 2015 Time:1pm - 2:30pm EDT US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Modernization of Investigator Oversight – Matching Current Requirements with...

Date: Tuesday, October 20, 2015 Time:1pm - 2:30pm EDT US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Finally…Update to ICH GCP E6 (R2) – Critical Updates You Must Know!

Date: Wednesday, October 28, 2015 Time:1pm - 2:30pm EDT US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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The CAPA Detective

Every industry has its detectives. Mechanics and journalists hunt for leaks. Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look...

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Finally…Update to ICH GCP E6 (R2) – Proposed Changes You Should Prepare For

Date: Wednesday, October 28, 2015 Time:1pm - 2:30pm EDT US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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WIB Profile: Embrace Change Management Or Expect To Fail

Risk management is a concern for all pharma companies, and the increasing rate of adoption of new approaches, such as risk-based monitoring, will keep it a concern for years to come. Of course with any...

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Should A Clinical Mastermind Run The FDA?

We all know that a primary driver of the high cost of drug development is clinical trials. The process is not only costly, but lengthy and difficult. And even once you complete the four phases and...

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6 Things To Know About FDA's Final Method Development & Validation Guidance

In July, the FDA released its final guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” to give companies a clearer picture of what they must have in their regulatory...

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Instructional Design for GMP Training – Improve Effectiveness and Measurability

Date: Thursday, November 5, 2015 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Understanding Cleanroom Microbiology – Building A Foundation For Compliance

Date: Monday, November 2, 2015 Time: 1pm - 2:30pm EDT Duration: 90 Minutes - Online Price:$299 - Includes Bonus Handouts!

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Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

Date: Thursday, November 17, 2015 Time: 1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Good Documentation Practices for Clinical Trials – Ensuring Air-Tight Results

Date: November 9, 2015 Time: 1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Survey Says: Technology Use In Clinical Trials Continues To Grow

How pervasive is the adoption of new technologies in clinical trials? DrugDev recently surveyed 572 clinical trial investigators from 11 countries to try and answer that very question. Their results...

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Best Practices for Deviation Investigations – Cost-effective Problem Correction

Date: Thursday, December 17, 2015 Time: 1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Competency-Based Training in a GMP Environment – Results Based on Roles and...

Date: Tuesday, January 12, 2016 Time: 1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Valuable Job Aids!

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How To Increase Patient Enrollment By 600 Percent

The process of getting patients to engage in a clinical trial is a headache that will keep many recruitment specialists awake at night. The Cancer Research Institute notes only two to three percent of...

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Answering Your Top 5 GCP Questions of 2015!

Date: Tuesday, January 26, 2016 Time: 1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts and 2015 GCP Survey Results!

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Electronic Investigator Site File: Digital Storing of Documents for...

Date: Thursday, January 14, 2016 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Lyophilization - Thermal Characterization as Part of an Empirical Process for...

Date: Wednesday, January 13, 2016 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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Design Controls 101 – A Practical Crash Course

Date: Thursday, January 14, 2016 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!

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