David Longwell

David Longwell, Senior Technical Consultant, is a quality and compliance executive at Longwell & Associates. With extensive experience in organizational leadership, quality and compliance, and chemistry, David is expert at planning, developing, implementing, and improving quality systems and analytical processes.

David’s key accomplishments include: delivering $1.0 million in savings by streamlining stability testing processes across three international labs; developing the OOS/OOT investigation process for the global NC/CAPA system; implementing a training plan for departments to meet GMP requirements; developing a regulatory and stability strategy for new device product CE submission in EU countries; implementing a global documentation process for departments across three international sites; and successfully completing 4 FDA audits and 6 KEMA audits with no major findings. He is a recognized expert at the creation and documentation of quality processes across multiple functions.

Previously, David has aligned worldwide franchise stability functions and development of global registration process (KEMA, JRA, FDA) which resulted in timely product registration. He developed a QA Stability Lab strategic deployment plan with resource requirements across the portfolio of strategic projects, with process maps for the Deployment area, and high-level project timelines, risks, and complexity models for emerging strategies. He has also acted as a stability subject matter expert (SME) for FDA/ISO audits.

David provides thorough knowledge of FDA (21 CFR Part 820/814); cGMP (21 CFR Part 210/211/200); international quality system requirements (ISO 13485 and ISO 9001); international stability requirement for Drugs and IVD’s (EN 13640, ICH Q1A (R2) and Q1E, CLSI EP25-P); and regulatory requirements for Medical Device traditional 510K, special 510K and Drug IND submissions. His core strengths include incoming quality, stability testing, method development, product analysis, post-market surveillance, supplier quality, CAPA systems, NC systems, internal quality audits, external quality audits, Process Excellence (DMAIC), process improvement, design control, compliance strategy, and team leadership.

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