York&Eagle  LLC

Service Areas

York & Eagle LLC , services to Medical Device, Pharmaceutical, Biopharmaceutical and API manufacturing industries including the Warehouses 

SERVICES
 

• Quality Assurance and Control functions
  • GMP auditing 
  • Certificate of Analysis 
  • Specifications Review
  • SOP Review 
  • Batch record review
• Auditing of contract development organizations
  • GMP compliance
  • Review of SOP’s, record-keeping, and training documentation
  • Training 

Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the required standards. During inspections, regulatory agencies often find problems related to training programs.

. We customize our programs to fit client needs. Our training course offerings include:

For all the applicable industries:

• GMPs
• GDPs ( Good Documentation Practices)
•  Root Cause analysis
• performing effective investigations 
• Managing Deviations, CAPAs and Change Controls
• ISO 13485 
• 21 CFR PART 211

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