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Quality and Compliance is a discipline that employs the use of quality assurance and reglatory compliance tools to determine the level of compliance with operational processes and procedures. Team Validation LLC provides the following Quality and Compliance services to its clients:


Quality System Development/Implementation/Redesign:

  • develop & implement Quality Manual
  • develop & implement Policies & Procedures (SOPs) and governance programs
  • develop & implement corrective action-preventative action (CAPA)
Training/Coaching:
  • develop custom training programs (GxP, Inspection Preparation, Supplier Management)
  • compliance coaching
  • process excellence program training and implementation
Inspection Readiness & Enforcement:
  • FDA Enforcement (483 Warning Letter) Response and Remediation Support
  • Recall Management
Product Development & Commercialization Support:
  • Mergers & Acquisitions
  • Licensing
  • Product Development Process Support/Advisory
Supply Chain Compliance (Audits and Assessments):
  • vendor selection criteria development & vendor qualification
  • supplier management training
  • third party service monitoring

Computerized System Validation:
Computerized Systems Used in Clinical Trials
Institute of Validation Technology
Food & Drug Administration (FDA):
FDA Website
FDA News Website
CBER
CDER
Sarbanes-Oxely
Sarbanes-Oxley Forum
Sarbanes-Oxley Forum2
Sarbanes-Oxley Law
HIPAA
HIPAA Advisory
HIPAA Compliance
HIPAA Training
OTHERS
Code of Federal Regulations
National Institutes of Health

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