​(862) 701 - 6222

CONTACT CENTERS

Bio/Pharma ~ Medical Devices ~ Health & Beauty ~ Food

 

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

 

 

 

SERVICES

·       (FDA) Inspection Readiness Planning / Mock Audits

·       Product Recalls Planning

·       Metrics and Dashboard Design

·       Computer Systems Validation and Electronic Records & Signatures (21 CFR Part 11) Assessment

·       Data Security & Privacy Audits

·       Validation Strategy / Document Review

·       Policy & Procedures Development

·       Training

·       Compliance / Risk Assessments

·       Third Party Management: RFP Process, document review, on-site overview, Quality Agreements/SLAs/Contracts

·       Project Management

·       Crisis Management / Business Continuity Planning

·       Change Control / CAPA Systems Development

·       Quality Systems / GxPs Audits & Development

·       Six Sigma Process Excellence / Process Mapping

·       Benchmarking

 

WEBINAR / SEMINAR / TRAINING OFFERINGS

·       How to Prepare for an FDA Inspection

·       Overview of FDA Regulations for Pharmaceuticals, Medical Devices, Health & Beauty and/or Food

·       How to Establish a Quality Program for Your Contact Center

·       Adverse Event Reporting: What You Need To Know

·       Validation & 21 CFR Part 11

·       Product Recall Preparedness: Lessons Learned

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