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
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