407-574-7195 info@bgfconsulting.com

Training Solutions

BGF can provide your organization with professional training services that increase the technical acumen of your staff and help ensure lasting compliance. We offer a variety of training programs from entry level cGMP, to laboratory analysis and Risk Management. Our training programs can be tailored to all levels of personnel and designed to meet the individual needs of your business. Additionally, we can assist your training team in developing a robust internal training program that is designed to meet regulatory requirements and provide long term compliance. BGF offers not only on site classroom lecture courses, but also hands on lab training, On the Job Training and “Train the Trainer” courses.

Key Services

Good Manufacturing Practices (GMP) Training

  • cGMP for all levels of Personnel
  • Good Documentation and Data Integrity Practices
  • Overview of the FDA Quality Systems Regulations
  • Laboratory OOS Investigations

Inspection Readiness

  • Preparinig for a Pre-Approval Inspection
  • Inspection Readiness & Personnel Interaction with Regulatory Investigators

Auditing

  • Internal Audit Program & Techniques
  • API & Supplier Training

Aseptic Gowning and Behavior

Prescription Drug Marketing Act (PDMA) & Sampling Handling

Validation

  • Validation Program Essentials
  • Cleaning Validation

Deviation Management & Root Cause Analysis

Corrective and Preventive Action (CAPA)

Batch Record Review & Release