Overview:
This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.
How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.
This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and 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:
· All Development, Quality and Research Scientists from regulated industries will benefit from this training.
· Quality Managers
· Assay Development Scientists
· Quality Analysts
· Research Scientists
· Risk Managers
Course Outline/Agenda:
Day One:
Lecture 1: Introduction/Fundamentals - Statistics
· Summary Statistics
· Graphical Techniques
· Hypothesis Testing
· Confidence Intervals and Tolerance Intervals
· Interactive Discussion/Questions
Lecture 2: ICH "Q" Series
· Q1 Stability Testing
· Q2 Validation of Analytical Procedures
· Q3 Impurities in New Drug Substances
· Q5 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human of Animal Origin
· Q6 Specifications
· Q7 GMP for API
Day Two
Lecture 3: Statistical Tools in Action (Workshop)
· Developing a Risk Management Plan
· Assay Validation
· Setting Specifications
· Q8 Pharmaceutical Development
· Q9 Quality Risk Management
· Q10 Pharmaceutical Quality Syste
Lecture 4: Integrating Statistics
· Regression - Q1
· Design of Experiments and ANOVA - Q8
· Sample Size - Q6
· Probability - Q9
· Interactive Discussion/Questions
Instructor/ Speaker Profile:
Mr Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.
Date, Venue and Price:
Location: Sydney, Australia
Date: August 4th & 5th, 2014
Time: 8:30AM to 4:30PM
Venue/Hotel: Hilton Sydney
Address: 488 George Street, Sydney NSW, Australia 2000
Price: $1595.00 (Seminar for One Delegate)
Discount: Register now and save $200. (Early Bird)
Until July10, Early Bird Price: $1,595.00, From July 11 to August 02, Regular Price: $1,795.00
Want to register by Wire Transfer?
Please call any of our representatives on 1800 447 9407 to help you completed the transfer.
Contact Information:
John Robinson
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
GlobalCompliancePanel
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161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
For More Info on This Seminar Kindly Go through the Below Link: http://bit.ly/ichguidelines
To Download Seminar Boucher: http://bit.ly/ICHpdf
GlobalCompliancePanel Seminar Gallery: http://bit.ly/1mCjvMb
Day 1 Outline/Agenda