MANUFACTURING/PACKAGING

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

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

 

SERVICES

·       Validation: Process, Cleaning, Utilities

·       Equipment Qualification

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

·       Validation Strategy / Document Review

·       Six Sigma Process Excellence / Process Mapping

·       Compliance / Risk Assessments

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

·       ISO Certification

·       (FDA) Inspection Readiness Planning / Mock Audits

·       Project Management

·       Business Continuity Planning

·       Change Control / CAPA Systems Development

·       Quality Systems / GxPs Audits & Development     

·       Policy & Procedures Development

·       Training

 

WEBINAR / SEMINAR / TRAINING OFFERINGS

·       Webinar on How to Prepare for an FDA Inspection

·       Seminar on Drug Quality Security Act: How Does It Affect You?

·       Webinar on Cleaning Validation at a Contract Manufacturer or Packager

·       Training Seminar on Overview and History of FDA and Validation



​(862) 701 - 6222