Webinar On Sampling: How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results

Compliance Trainings, Canada
2015-05-12

Description :

The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping companies speed up development and improve their operations. In addition the FDAs new Process Validation Guidance promotes Continued Process Verification. Sampling is an essential element of both process and product development and continued process verification. This raises the question “How Large a Sample Do I Need?”

This webinar provides some practical and useful answers to this question. Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, process and product development experimentation and process monitoring for process stability and capability is discussed. A comparison is made of the square root (n)+1 sampling rule with the ANSI Z1.4 sampling system for process monitoring including incoming raw materials, in-process manufacturing and finished product. The value of a systems approach to sampling and practical tips, traps and guideline for sampling is discussed. The presentation includes portable methods for making power calculations for experimental design. The concepts and methods involved are introduced and illustrated with pharmaceutical and biotech case studies and examples.

Areas Covered in the Session :

Principles for developing useful sampling plans and procedures

When “Square Root (n)+1” is a valid sampling plan

Creating a process sampling system using ANSI Z1.4 Sampling Plans

Sampling plans for monitoring process stability and capability

Practical power calculation procedures for determining appropriate experiment size

Plans for sampling tanks and blenders

How to use sampling data to get early warning of impending process problems

Tips, Traps and guidelines for developing successful sampling plans

Who Will Benefit:

Department Managers

Quality Engineers

Research and Development Scientists

Biologists and Microbiologists

Process and Manufacturing Engineers

Quality Assurance Personnel

Executives

Supply Chain Professionals

Accounting Professionals

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

Ronald D. Snee, PhD, is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture and W.J.Dixon Consulting Awards as well as numerous other awards and honors. He is a frequent speaker and has published 5 books and more than 255 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.

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