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GxP, 21CFR Part 11 (ERES), training, audits, safety, QC/QA, validations

 

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Welcome to CL Tech. Inc.

 

Benefits of becoming my Affiliate:

  • Shared Membership access to many organizations = cost reduction on annual membership fees.

    ASQ / NIST / ACS / ASTM / ISPE / PDA, etc.

  • Shared documents.  You don't have to purchase expensive documents.

  • Get more clients.  We refer you to a client because we know you are hard working and provide the best services.  We know your capabilities and create a win-win situation between clients and our Affiliates.

Contact me if you are interested in joining my Affiliate network of professionals.

 
Cezar Lucki, BS Bio.Sci., AS Psych. - Founder, Validation Specialist, Quality Engineer

After receiving a degree at University of California at Irvine, emphasizing in chemistry and microbiology, Cezar entered the Pharma / Biotech / Medical Devices Industries in 1995 performing Quality Control tasks in Environmental Monitoring, Analytical Chemistry, Sterility/Media and Microbiology between McGaw - B.Braun and Allergan.  He started CL Tech. Inc. in 2000 serving clientele from startups to fortune 100 companies.  Has assisted and solved hundreds of challenging CAPA's.  Has vast experience in equipment, facility/clean-room, and Part 11 validations.  Provided safety, training, quality engineering and statistical support for several employers and clients.   Presented seminars in the USA, Spain, Korea, and other countries on Part 11, Validations, Audits, QC techniques, etc.  Has worked since 1995 in production / QC / R&D environments for API, IV, medical devices, cosmetics, nuclear, biochemical, optics, ophthalmic, solid dose, liquid drug, recombinant, IVD, and plasma related manufacturing.

 

Network of Professionals

 
 
GLP Support
Anne E. Maczulak, MBA, PhD

Improves, initiates and implements FDA or EPA Good Laboratory Practices in small and growing companies, academic research laboratories, and analytical labs:

 

Services

  • SOP writing and editing

  • Document, Data, Protocol and Report Quality Control

  • GLP & Microbiology Training

  • On-site audits and prompt written reports

  • Technical Reports, Procedure Manuals and Training Manuals

Serving the following industries:

  • Biotechnology

  • Consumer products & Specialty chemicals

  • Academic research laboratories

  • Forensic laboratories

  •  Pharmaceuticals

  • Analytical laboratories

  • Environmental research

 

 
  

Certified Industrial Hygienist

Tiffany Taylor, President

EH&S Resources Inc will help your company develop comprehensive environmental programs that not only meet regulatory standards, but also surpass them.  Services Include:

  • Environmental Exposure Assessments

  • Environmental Permits
  • Unified Hazardous Waste and Hazardous Management Regulatory Program
  • Reports, Reports and More Reports

 

  
   
 

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CL Tech. Inc. © 2004 - Quality Assurance, Validation Services, and Quality Engineering Services