Let me show you how leading-edge quality systems management can improve your company’s productivity and profitability.

Experience includes:

•            Tenure in the industry

• ·         Validation design and execution (process, cleaning and method validation)

• ·         Lab management skills (author of two books on the subject)

• ·         Process improvement and cost reduction skills (Six Sigma and Lean)

• ·         Team building and motivational successes

• ·         Consent decree and Warning Letter remediation.

• ·         Quality metrics design

• ·         Cross-functional collaboration

• ·         FDA audit and remediation

• ·         Hosting customer audits

• ·         Public speaking/presentations

• ·         Leadership

•  ·         Designed and executed  process, cleaning and methods validations.

• ·         Authored hundreds of  reports and SOPs.

• ·         Hosted and conducted audits (FDA and customer).

• ·         Trained and mentored.

• ·         Heavily involved in Quality systems management (QA/QC)

• ·         Method development.

• ·         Executed Tech transfers

• ·         Performed Equipment qualification.

• ·         Facilitated Process improvements (plant and laboratory)

• ·         Implemented Six Sigma and Lean applications.