Mitchell Januszewski


Principal


Mitch Januszewski began his career as a mechanical engineer in regulated companies like Baxter. He gained much experience surviving every kind of FDA audit and that became the impetus for his first consulting firm, Oak Grove Technologies.

At Oak Grove Technologies, Mitch established global cGMP strategies for pharmaceutical, biologics, and medical device manufacturing, production, and distribution, executed cGMP compliance audits, and developed and implemented remediation plans in response to FDA observations. He conceived the design and compliance review of facilities and support systems, developed and implemented cleaning validation strategies, and also designed pharmaceutical high purity water (WFI and USP Purified) and clean steam production and distribution systems.

After he sold Oak Grove, his entrepreneurial spirit led him to founding Regulatory Compliance Associates® Inc. with his friend and colleague, Steve Schultz. Since 2000, Mitch, as President and Principal of RCA, has grown the company to hundreds of clients around the world.

In 2013, Mitch and the other shareholders, Steve Schultz and Mike Parkes, took a step back from daily operations. Mitch has remained Chairman of the Board of Directors and will continue to work closely with Brian Matye in his role as CFO. As RCA redefines its vision, Mitch will work closely with the new CEO, Erika Porcelli.

At the inception of RCA, Mitch was responsible for the development and implementation of Regulatory Compliance Strategies, Validation Master Plans, and Validation Protocols for pharmaceutical manufacturing facilities, utilities, packaging operations, and distribution processes. Other achievements include the development of Regulatory Gap Analyses and implementations of Quality Systems.

Mitch’s nearly 40 years as a pilot are integral to his business. With the company plane, he can respond quickly to clients who call today and need RCA’s help tomorrow. Mitch enjoys building relationships with his clients and employees around the globe. He takes his passion for flying into volunteer activities with Angel Flight, an organization that flies seriously ill patients to their specialized medical care.

A graduate of the University of Wisconsin, Mitch earned his Bachelor of Science in Mechanical Engineering. He resides in Burlington, Wisconsin.

I'm Interested in Learning More About RCA

News

Regulatory Pathways for Medical Device and Pharmaceutical Filings and cGMP Compliance Considerations...
Read More

News

Regulatory Pathways for Medical Device and Pharmaceutical Filings and cGMP Compliance Considerations...
Read More

News

Regulatory Pathways for Medical Device and Pharmaceutical Filings and cGMP Compliance Considerations...
Read More
PharmTech PDA Podcast – 2019 PDA Quality Week...
Read More
Calling All Active PDA Members – Vote Now in PDA’s 2020 Officers and Board of...
Read More