New Training Helps Pharmaceutical and Medical Device Companies Navigate “Sea Change” in FDA Process Validation Guidance

Minitab, the leading provider of software for quality improvement, will offer training on statistical tools for FDA process validation.

October 17, 2011

STATE COLLEGE, Pa. —  As the pharmaceutical and medical device manufacturers wrestle with a classic instance of “be careful what you ask for,” Minitab, LLC. is responding with a new training course designed to help compliance and quality professionals navigate a drastically altered regulatory landscape. 

As members of one of the most heavily-regulated industries, pharmaceutical and medical device makers have long lamented to FDA regulators that the industry should have flexibility in how to validate its processes. They got their wish in January 2011, when FDA issued new validation guidance that provides that flexibility.

The new validation guidance no longer tells companies how many samples they need to pull or how many batches they need to run. Instead, companies must validate processes at each point in the product development pipeline. The FDA has recommended three stages for process validation in the new guidance document.

Pharmaceutical quality improvement practitioners can learn how to use data analysis to validate processes within each FDA-recommended stage by attending the Statistical Tools for Process Validation training series.

The three-day training course is offered and conducted by Minitab, LLC., the leading provider of software for quality improvement and statistics education. Online registration for these and other Minitab training events is available at

The course is tailored for professionals working in manufacturing-based pharmaceuticals and medical devices companies, emphasizing the application of statistical tools to the different stages of the FDA 2011 Process Validation Guidance.

Course materials include real-world examples and exercises, such as performing stability analysis to establish product expiration dates.

“Participants will learn to select the right statistical tool for each stage of the FDA 2011 Process Validation Guideline and then how to correctly interpret the results of the analysis,” says Jim Colton, Minitab technical training specialist, who will teach the course, bringing to it his extensive experience mentoring pharmaceutical and medical device manufacturers in statistics.

Topics covered will include t-Tests for testing targets, Gage R&R for measurement system verification, Capability Analysis for Normal and Attribute Data, Variables and Attribute Control Charts, Acceptance Sampling for incoming/outgoing inspections, Regression for modeling observational data, ANOVA, DOE for process improvement, Stability Analysis for establishing expiration dates, and Reliability.

Minitab trainers are seasoned statisticians with years of experience implementing quality improvement projects. They make complex concepts easy to grasp, and are highly regarded for their engaging style and personal attention.

Colton, who has more than 12 years of experience as a Minitab trainer, developed his industrial skills at companies including Kellogg’s and Pratt & Whitney.  “Working daily with product developers at Kellogg’s and engineers at Pratt & Whitney taught me how to explain statistics in practical terms,” he says.

About Minitab

Minitab, LLC. is one of the world’s leading developers of statistical and process improvement software. Thousands of distinguished companies use Minitab software, including Toshiba, DuPont, Boeing, Royal Bank of Scotland, Nestlé and Pfizer. Minitab products are backed by outstanding services, including training, e-learning opportunities, and free technical support.

Minitab, LLC., headquartered in State College, Pa., operates offices in the United Kingdom, France and Australia and has additional representatives throughout the world.

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