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

Share Article

Minitab, the leading provider of software for quality improvement, will offer training on statistical tools for process validation in the Los Angeles area February 6-10.

Minitab, the leading provider of software for quality improvement, will offer training on statistical tools for process validation in the Los Angeles area February 6-10.

Minitab, the leading provider of software for quality improvement, will offer training on statistical tools for process validation in the Los Angeles area February 6-10.

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

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 in the Los Angeles area 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. It will be held February 6 – 10 at MicroTek, 222 North Sepulveda Blvd., Suite 1240, El Segundo, CA 90245.

The full week of training is offered and conducted by Minitab Inc., the leading provider of software for quality improvement and statistics education. The full five days of training costs $2,125. People who register for two or more days of training and pay before January 27, 2011 receive a 10% early-bird discount. In addition, two or more people from the same organization receive a 5% discount if they register before February 6. Online registration is available at http://www.minitab.com/training/instructor-led/training-details.aspx?eventId=958

The courses are tailored for professionals working in manufacturing-based pharmaceuticals and medical devices companies, and emphasize 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 five day-long courses are detailed below:

Statistical Tools for Process Validation (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.

Response Surface (Day 4)

Participants learn to create response surface experiments, analyze experimental results, and find factor settings that simultaneously optimize multiple responses while being sensitive to the resources required to obtain that information. Topics include Central Composite and Box-Behnken Designs, Calculations for Steepest Ascent, Overlaid Contour Plots and Multiple Response Optimization.

DOE in Practice (Day 5)

Participants learn to handle common DOE scenarios where classic factorial or response surface design and analysis techniques are neither appropriate nor possible. Participants explore the opportunities to minimize costs or variability while simultaneously optimizing an important product or process characteristic. Topics include ANCOVA, Unbalanced Designs, Split-Plot Designs, Multiple Response Optimization and Binary Logistic Regression.

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.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Carly Barry
Minitab Inc.
+1-814-753-3918
Email >

Eston Martz
Minitab Inc.
+1-814-753-3270
Email >
Visit website