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The Compliance Store

 

AUDIT SERVICES

Our Audit Services enable you to be proactive with regards to your quality assurance and regulatory compliance status.

  • PAI Preparation Audits - don't find out too late what is wrong
  • Vendor/Contract Mfg Audits - raw materials, components or services
  • General Assessment - verify that you are in compliance with federal regulations
  • GMP Gap Analysis - evaluate where you are and where you should be
  • Full Audit Service - our 5-step approach is complete and efficient
  • Due Diligence - evaluate your next acquistion before purchase

 

GMP TRAINING

Is GMP a way of life at your company?  Our Training Programs can provide a hands-on solution to your training needs:

  • In-house GMP Training--our trainer will come to your location!
  • Annual GMP Training--a wide variety of topics to choose from!
  • New Employee Orientation--to bring your new hires up to speed!
  • Webinar Training--Coming Soon!

 

ACCREDITATION PROGRAMS

Our 20-week Quality Assurance Accreditation Program is targeted to employees with five years or less experience and is conducted by one-hour telephone coaching calls.  With this program, you can provide your employees with the skill sets necessary to make quality-conscious and compliant decisions.  Click here for details and an application form and FAQs.


 

CONTACT US

Call us  at 513-860-3512 to discuss how we may be of service to you, or email us at info@compliance-insight.com with questions.


 
 

BIOSAFETY CONSULTING

Are you up to date on the latest developments in biosafety and viral testing compliance? Our Biosafety Consulting services can provide you with the expertise needed to design and develop global regulatory product testing strategies at all stages of product development.


 

REGULATORY CONSULTING

Compliance Insight can assist clients in the following areas:

  • Project Management--new facility construction, validation planning
  • Regultory Filings--IND, NDA, ANDA, 510k
  • 483 Resolution--
  • Warning Letter response--
  • FDA liason
  • CAPA
  • Investigations
  • Viral Study Planning and Review
  • Cleaning Validation Consultation
  • Validation Planning and Review
  • Custom Standard Operating Procedures

 
THE COMPLIANCE STORE

Coming Soon!  For the do-it-yourselfer, The Compliance Store will offer training booklets, customizable SOPs,  reference materials and guidelines at reasonable costs.

 

Compliance Insight, Inc.
513-860-3512
Copyrighted 2001 - 2011, Compliance Insight, Inc.