2014 - 2-day In-person seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penaltie at Miami FL

Overview:
This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.
This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical or biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.
Who Will Benefit:
Quality Managers
Assay Development Scientists
Quality Analysts
Research Scientists
Risk Managers
Quality Managers
Areas Covered in the Session:
Introduction to ICH Q Series
Introduction/Fundamentals - Statistics
Integrating Statistics into protocols
Developing a risk strategy
Course Outline:
Day 1 ? Agenda
Lecture 1: Introduction/Fundamentals - Statistics
Summary Statistics
Graphical Techniques
Hypothesis Testing
Confidence Intervals and Tolerance Intervals
Lecture 2: ICH "Q" Series
Q1 Stability Testing
Q2 Validation of Analytical Procedures
Q3 Impurities in New Drug Substances
Q4 Pharmaceutical Development
Q5 Quality Risk Management
Q6 Pharmaceutical Quality System
Day 2 ? Agenda
Lecture 3: Integrating Statistics
Regression - Q1
Design of Experiments and ANOVA - Q8
Sample Size - Q6
Probability - Q9
Interactive Discussion/Questions
Lecture 4: Statistical Tools in Action
Developing a Risk Management Plan
Assay Validation
Lecture 5: Setting Specifications
ABOUT SPEAKER ?
Mr. Steven Walfish brings is the founder and President of Statistical Outsourcing Services. He brings nearly 20 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
Location: Boston, MA| 23rd & 24th January 2014 |9:00AM-6:00PM EST
Venue: Courtyard Boston Logan Airport
Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
Price: $1,295.00
Register now and save $200. (Early Bird)
Until December 10, Early Bird Price: $1,295.00
from December 11 to January21, Regular Price: $1,495.00
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.p...
Event Link: http://bit.ly/1cDrsYL
GlobalCompliancePanel,
USA, Livermore Common, Fremont,
CA 94539, USA Phone: 1800 447 9407