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

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Minitab, the leading provider of software for quality improvement, will offer training on statistics for pharmaceuticals and medical devices in the Edison, N.J. area May 21-23.

Minitab, the leading provider of software for quality improvement, will offer training on statistical tools for process validation in the Edison, N.J. area May 21-23.

Minitab, the leading provider of software for quality improvement, will offer training on statistical tools for process validation in the Edison, N.J. area May 21-23.

The course is tailored for pharmaceutical and medical device companies, emphasizing the application of statistical tools to the different stages of the 2011 FDA Process Validation Guidance.

As the pharmaceutical manufacturing industry wrestles with a classic instance of “be careful what you ask for,” Minitab Inc. is responding with a new training course designed to help compliance and quality professionals navigate a drastically altered regulatory landscape.

As one of the most heavily-regulated industries, pharmaceutical manufacturers 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 the FDA issued new validation guidance that provides that flexibility.

According to the FDA's new validation guidance, companies are no longer told 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 in the Edison, N.J. area can learn how to use data analysis to validate processes within each FDA-recommended stage by attending the Statistics for Pharmaceuticals and Medical Devices training series. It will be held May 21 – 23 at ExitCertified, Raritan Plaza III, 105 Fieldcrest Avenue, Edison, N.J. 08837.

The training is offered and conducted by Minitab Inc., the leading provider of software for quality improvement and statistics education. The full three days of training costs $1275. People who register for two or more days of training and pay before April 21, 2012 receive a 10% early-bird discount. In addition, two or more people from the same organization receive a 5% discount if they register before May 21. Online registration is available at http://www.minitab.com/en-US/training/instructor-led/training-details.aspx?eventId=998

The courses are 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.

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.

The skills covered in the three day-long courses are detailed below:

Statistics for Pharmaceuticals and Medical Devices (Days 1-3)
Topics 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. Also covers importing data, formatting data, creating/editing graphs and general tips.

About Minitab
Minitab Inc. 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 Inc., 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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Carly Barry
Minitab Inc.
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Eston Martz
Minitab Inc.
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