Bill Kracht Consulting Services
Personal Service – Proven Success

Make your quality system and regulatory compliance efforts work for you – not the other way around!!

William R. (Bill) Kracht

Bill Kracht Consulting Services
403 First Street
Manistee, Michigan 49660
Phone: 231.398.0669
Email: billkracht@chartermi.net

FDAcGMP

17025

 

FDA "Quality Systems Approach"

GLP

ISO 9000

+ Many Others
  • 30+ years experience in pharmaceuticals, chemicals, plastics, dietary supplements, cosmetics, personal care products, and other industries; manufacturing, supply chain, laboratory and service environments
  • Experienced trainer, auditor, consultant – will customize to meet your needs
  • 15 years as Quality Systems Manager and main FDA contact for large site producing pharmaceuticals, food additives, and medical device materials (multiple plants and multiple labs), with ZERO FD-483 noncompliances written during that time!
  • Certified Quality Systems Lead Auditor by the US Registrar Accreditation Board
  • Chairman of the International Conference on ISO 9000 and Related Standards (2002, 2003, 2004)
  • Coached / consulted for many product and service groups through ISO or QS-9000 registration – all passed on their first attempt
  • Developed general and customized materials and trained thousands (both classroom and web-based) on FDA cGMP, GLP, ISO 9000, QS-9000, internal auditing skills, etc.
  • Frequent speaker, organizer, session chair, and/or expert panel member on above topics at national and international conferences

Audits or Assessments of Quality Systems

1. Experience Counts!

  • Certified Quality Systems Lead Auditor (certified by US Registrar Accreditation Board for ten years)
  • Master trainer of hundreds of auditors in the auditing process as well as in auditing against specific standards
  • Nearly 1000 first-party and second-party audits conducted, most as the Lead and/or sole auditor
  • Trained and experienced in auditing against many different standards and criteria

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    2. "Internal" Audits

    1. Thorough, thoughtful, and insightful audits / assessments of your whole system or subsystems of your operations conducted in a positive, "win-win" atmosphere
    2. Concrete data to support your management decisions
    3. Consistency of the data you receive – same auditor across your systems
    4. Use to replace or supplement your current internal audit program
    5. Fresh pair of eyes looking at your systems, but you retain control of the process, priorities, and results
      6.

    3. Supplier Audits

    1. Assure to quality of the inputs to your systems – raw material, packaging, or service suppliers; contract manufacturers, contract packagers, outside testing laboratories, etc.
    2. Concrete data to support your management decisions
    3. Consistency of the data you receive – same auditor across your systems
    4. Use to replace or supplement your current audit program without disrupting the other priorities of your staff
      5.

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    Train at Your Facility – Save Time and Money!

    1. Experience Counts!

  • Developed general and customized training materials on overall quality systems plus specific standards such as FDA cGMP, GLP, ISO 9000, QS-9000, ISO/TS 16949, internal auditing skills, etc.
  • Thousands trained in person over 20+ years; also developed web-based training modules
    •

    2. Maximum Benefit for Your Training Dollar

  • Train up to dozens at your facility for the cost of sending one or two to outside training
  • Less disruptive to your staff – no travel involved for them
  • Material can be customized to your organization’s issues and priorities
  • In-house training allows confidential setting for discussion of sensitive issues
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    Consulting Services for Individuals or Groups

    1. Get the results you want!

  • Primary consultant for dozens of product and/or service groups through their ISO 9001 / 9002 or QS-9000 registrations – all passed their registration audits on their first attempt.
  • 15 years as Quality Systems Manager and main FDA general GMP / GLP consultant for large site producing pharmaceuticals, food additives, and medical device materials (multiple plants and multiple labs), with ZERO FD-483 noncompliances written during that time!
    •

    2. Integrated quality management philosophy

  • One quality / management / operating system, not multiple systems with overlaps and disconnects

  • Avoid the "quality program of the day" syndrome

  • Make your quality system work for you – not the other way around!

  • Focus on tangible, measurable results

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