Jenna Carlson

About Jenna Carlson

Cleaning Validation Subject Matter Expert (SME) with over 24 years of experience in the pharmaceutical and biopharmaceutical industries. Published expert in Cleaning Validation as recognized by authorship of PDA Technical Reports #29,#49, Cleaning & Cleaning Validation Volume 1, and various other articles and industry presentations. Established track record supporting successful approval of new license applications, extensions of licenses, and dissolution of consent decrees. Strong track record of leading and directing cross-functional teams to accomplish critical strategies in compressed timeframes. Extensive knowledge of global cGMP requirements. Experienced in authoring CMC regulatory submissions, developing storyboards, and speaking on behalf of companies during regulatory inspections.Core competencies include: cGMPs • Cleaning Validation • Quality Assurance • Process Validation • Equipment Validation • Facility and Utility Validation • Quality Systems • Contract Manufacturing • Auditing • Regulations • Lot Release • Product Transfer • Sterilization • CMC Regulatory Submissions • Remediation Leadership • Inspection Preparation & Support • Inspection Respones • Training • Quality Risk Management • Project Management • Deviation Investigations • Operational Excellence (Lean and Six Sigma) • Process Redesign and Change Management

Experience

1. President & Quality Consultant

   Mindful Quality

   May 2019 — Present · Santa Rosa Beach, FL, US

   Support clients’ regulatory inspections and develop client observation responses.• Present facility, utility, equipment, process, and cleaning validation programs on behalf of clients during regulatory inspections.• Advise and train clients on designing cleaning programs, processes, and validation.• Advise clients with design, validation, and water system monitoring program.• Biofilm remediation of water and chromatography systems• Create and revise validation standards.• Perform assessment and remediation of clients’ overall validation program including facility, utility, equipment, process, cleaning, and shipping validation packages.• Develop and manage clients’ validation program gap remediation projects.• Draft and review inspection storyboards for clients and train internal SMEs on how to present the company’s message to regulatory inspectors in a clean and consistent manner that achieves company goals.• Provide guidance and draft clients’ cleaning validation master plans (CVMP) and related cleaning program procedures (e.g, visual inspection, cleaning verification, and continued cleaning verification, etc.).• Provide guidance and draft clients’ validation master plans, validation project plans, and validation program procedures and templates.• Optimize clients’ quality and manufacturing processes and procedures. • Draft cleaning cycle development protocols, reports and validation protocols and reports for clients.• Conduct GMP audits on manufacturing and testing facilities.• Lead clients’ validation teams comprised of internal staff and contract personnel.

Education

• Southern Illinois University, Carbondale

  BS, Chemistry

  1996 — 1998

• UW Professional & Continuing Education

  Certificate, Biotechnology Project Management