Valerie Welter
Valerie Welter has been working within the regulated industry for nearly 17 years, holding senior positions in quality system management and pharmaceutical manufacturing. She is currently employed as Director, Quality Compliance and Sterility Assurance for Regulatory Compliance Associates, Inc. (RCA) supporting the remediation of quality systems in the pharmaceutical and medical device industry.

Ms. Welter has expertise in compliance, pharmaceutical manufacturing, aseptic processing, biological laboratory management, manufacturing site validation, quality training, quality program management and lean quality initiatives. In addition, she has conducted a wide range of internal and external quality system audits. She has delivered numerous technical presentations on a variety of topics including GXP documentation and pharmaceutical information to regulatory agencies, industry trade organizations, and other technical groups.

Ms. Welter holds a Bachelor of Science degree in microbiology from The University of Missouri. She is a member of numerous professional associations and has been an Editorial Advisory Board member of the Journal of GXP Compliance and the Journal of Validation Technology since 2009.

Ms. Welter can be reached by e-mail at v.welter@rcainc.com or through RCA’s website, http://www.rcainc.com.

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