TCG offers a variety of services to FDA-regulated companies. We offer practical, tailored solutions that align global quality capabilities with business strategy. We will work with your team to create an atmosphere of strong compliance.

GMP training 21CFR 211
Quality System Regulation Training
FDA 101: Understanding the Regulatory Process
Inspection readiness
Data integrity

Tanksley Consulting Group Pharmaceutical Quality Regulatory Compliance Consulting. Sarah Tanksley

TRAINING TOPICS

Services

We provide strategy and training to ensure the design of processes and operation of manufacturing facilities that fully comply with Federal Drug Administration’s current Good Manufacturing Practices regulations.

Consulting Services & Training

constructive • productive • instructive

+1 (757) 870-3739

info@tanksleygroup.com

+1 (757) 870 - 3739

FDA Submission / Application Review
Routine cGMP and best practices audits
Mock inspections
Inspection preparation and coaching
483 response preparation and/or review
Warning letter response assistance
Remediation activities
Third-party due diligence audits
Data integrity audits, life-cycle mapping, and remediation
Deviation investigation and CAPA assistance
Out of specification and laboratory investigation assistance
Quality & Compliance Policies & Standard Operating Procedure Preparation & Optimization
Quality Assurance and Quality Control Training (FDA, GMP, Validation)
Quality System Development, Assessment and Optimization
Batch record review and optimization
Process mapping and streamlining
Compliance strategy planning
Technical support for law firms