Thomas Happ
107 Knapp Road
Lansdale, PA, 19446-1716
Phone: (215) 806-9705
Fax: (215) 362-4596
E-mail: happ@snip.net

Hands-on functions of an analytical Bench Chemist; Supervisory functions of Laboratory Management

Also provides:

  1. Instrumentation
    • IQ/OQ/PQ; LIMS Development and Implementation
  2. Training
    • Hands-on bench level training in documentation, analytical technique, wet chemistry, instrumental analysis, problem solving and safety; customized GMP training.
  3. GMP Compliance
    • GMP and Pre-Approval Inspections
  4. FDA Counseling
    • Assistance before, during, and after an FDA inspection; Direct inspection participation; Compliance deficiency assessment and remediation.
  5. Technical Writing
    • Test procedures, quality standards, calibration & maintenace programs, manufacturing process descriptions, validation protocols and qualifications.
  6. "Ounce of Prevention" Newsletter
    • Identifies less obvious sources of FDA citations and provides practical preventative suggestions. Available at No Cost. E-mail me your request for a descriptive brochure and newsletter.
  7. Laboratory Notebook Docuentation Training Seminars
    • Actively utilizes audience participation in detailing how to maintain a GMP compliant analytical laboratory notebook. Approximately 1 hour, no charge. E-mail for availability.
  8. Structure Laboratory Notebook Design Service
    • GMP compliant workbook style includes test procedure, dilutions, calculations, test disposition, check off boxes and fill-in-the-blank data entry, reagents, instrumentation, preparation data, etc. E-mail for further information and sample pages.