Cindy Mitman

About Cindy Mitman

Dynamic Quality Executive | Sterile Compounding Expert | Regulatory Strategist | FDA Panelist | Passionate Educator & SpeakerCredentials: PharmD | MBA | Board Certified Sterile Compounding Pharmacist (BCSCP)| Certified Quality Auditor (CQA)I’m a forward-thinking leader in Quality, Operations, and Regulatory Affairs with 20+ years of end-to-end pharmaceutical experience spanning R&D, hospital pharmacy, sterile manufacturing, quality systems, and commercial strategy. With a distinctive blend of pharmacy licensure, advanced certifications, and leadership in 503B and GMP-regulated environments, I specialize in turning compliance into a strategic driver of business growth and operational trust. Successfully led FDA, DEA, and state board inspections with zero major observations Designed and launched multiple state-of-the-art sterile compounding cleanrooms Delivered thought leadership as an FDA panelist on Quality Culture, Process Validation, and Outsourcing Strategy Contributed to ISMP Guidelines shaping national standards in perioperative and IV compounding safetyRooted in hospital pharmacy and elevated through years in GMP operations, quality oversight, and commercial alignment, I understand the critical intersection between urgency and integrity when it comes to batch release. I’ve lived both sides and understand both the pressure and the purpose, ensuring patients receive safe medications on time, every time.I’m consistently trusted by commercial teams, operational leaders, and quality peers alike. My approachable leadership style, coupled with deep technical expertise, inspires confidence and builds long-term partnerships. It’s why former colleagues and cross-functional teams continue to turn to me for collaboration, insight, and problem-solving.From implementing robust quality management systems and driving investigations to true root cause, to optimizing manufacturing processes, elevating aseptic training, and navigating complex audits, I bring both strategic clarity and a human-centered approach to every challenge.Let’s connect to exchange insights on quality assurance, quality systems, sterile compounding, 503B operations, or advancing quality leadership across the pharmaceutical industry.

Experience

1. Principal Consultant

   Clm Solutions, Llc

   Dec 2025 — Present

   As Principal of CLM Solutions, LLC, I help 503A pharmacies, 503B outsourcing facilities, and pharmaceutical organizations strengthen quality systems, improve operational performance, and prepare confidently for regulatory scrutiny.My consulting work integrates 20+ years of hands-on experience in sterile compounding, commercial manufacturing, PIC leadership, and hospital pharmacy operations. I support clients in quality system development, deviation/CAPA execution, workflow optimization, multi-state licensing, and FDA/State inspection readiness.I also provide specialized expertise in 503B product and package labeling compliance, a frequent FDA Form 483 observation and critical component of regulatory success.Training is a core part of my practice. I develop and deliver programs for aseptic operators, QA and operations teams, leadership groups, and cross-functional staff requiring GXP or documentation training. I also advise organizations on structuring customer site visits and audits, helping teams communicate their quality and operational strengths clearly and effectively.A signature offering of CLM Solutions is commercial team education for 503B outsourcing facilities, an area significantly underserved in the industry. I help sales and business development teams understand sterile compounding fundamentals, clinical use cases, hospital and ASC needs, and compliant value communication. Training is available for national sales meetings or recurring virtual sessions.Core consulting capabilities include:• QMS implementation and QA leadership support• USP, cGMP, EM guidance, aseptic training• Labeling compliance review and remediation support• PIC support and multi-state licensing strategy• Inspection preparedness and regulatory response• Training for aseptic operators, QA/operations personnel, leadership and commercial teamsMy mission is to provide practical, compliant, and sustainable solutions that help organizations grow with confidence.

Education

• DeSales University

  Master of Business Administration (MBA)

• Lehigh University

  Bachelor of Science (B.S.), Neuroscience

• Methodist University

  Bachelor of Science (BS), Chemistry

• University of North Carolina at Pembroke

  Bachelor of Science (B.S.), Pre-Medicine/Pre-Medical Studies

• Wayne Community College

  Associate of Science (A.S.), Pre-Pharmacy Studies

• Temple University School of Pharmacy

  Doctor of Pharmacy (Pharm.D.), Pharmacy