America's Top Tradeshow Directory | Events In America
Facebook Linked In Twitter Videos

Paid membership required to see this information

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory (drug development) and clinical development (drug/device) procedures such as analytical methods in validation and acceptance criteria in calibration procedures, risk management and process monitoring as well as dealing with uncertainties and other relevant issues. It is not a course in statistics but introduces the participant to a hands on approach to the statistical techniques one uses, how they are applied and reasonably interpreted and understood. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations.

In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are accepted, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how organizations are expected to apply these guidelines.

Learning Objective:
Upon completing this course participants should be able to:

Evaluate linear and other quantitative measurement procedures.
Distinguish the difference between confidence and tolerance intervals.
Evaluate the sensitivity of the sample size in given procedures.
Evaluate laboratory/clinical data results based on risk management and design space issues.
Interpret alternative approaches to statistical process control in reference to data distributional formats.

Who will Benefit:
This course is designed for people responsible for developing, maintaining and/or improving clinical and laboratory monitoring programs and interpreting the results from such. This includes individuals that have data monitoring responsibilities. The following personnel will benefit from the course:

Quality Managers
Quality Professionals
Assay Development Scientists
Research Scientists
Clinical/Laboratory Data Analysts

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:
http://www.complianceonline.com/understanding-the-statistical-considerations-for-quantitative-ich-guidelines-seminar-training-80281SEM-prdsm?channel=eventsinamerica

If the Understanding the Statistical Considerations for Quantitative ICH Guidelines: 2-Day Hands-on Workshop is important to your business, act now and make the appropriate connections. See the contact information below.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. EventsInAmerica.com and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Website: http://www.complianceonline.com/understanding-the-statistical-consider...
Conference/Event Dates: 12/08/2016 - 12/09/2016
Conference/Event Hours: 8:30 AM to 4:30 PM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Clinical Pharmacology, Professional Healthcare, Sciences
Estimated Attendance: 30
Cost to Attend: One Registration - $1599
Audience: Quality Managers
Quality Professionals
Assay Development Scientists
Research Scientists
Clinical/Laboratory Data Analysts
Laboratory Data Managers
Venue: Venue TBD
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

Advance Networking

How do I show up here?
 

Personal Notes

Add a note here, it is only visible by you.

New Search Contact This Event