cGMP Auditing & Training

Synergy provides cost-effective training programs and materials for regulatory compliance. We develop and produce customized, competency-based training courses, designed to help organizations improve employee competence and skills.

Our expert trainers are experienced hands-on practitioners in their field, taking training beyond theory, providing your employees valuable real-world insight. Throughout our course curriculum, we provide high-quality consistent training for every level of your organization.

All Quality Compliance training courses are modules that can either be taught at your location, or remotely by Webinar. Due to our extensive list of courses, contact us about a specific course and we will send out all the details. Additionally, as part of our training service, we will work with your staff to match your organization with the proper trainer, and devise a training schedule that fits around your employee’s primary tasks.


Examples of Quality Compliance’s certified training courses

  • How to Conduct Effective Batch Record Reviews
  • Complaint Handling: An Insider’s View of Effective Management Practice
  • Introduction to Validation and its Documentation
  • The Basics of Conducting Effective Validation: A GMP Training Session for New Employees
  • FDA’s NEW Process Validation Guidance: Actions You Need to Begin Taking NOW!
  • Establishing and Implementing Successful Computer Systems Validation
  • CAPA: Implementing an Effective Program: Lessons from the Trenches
  • CAPA Training Workshop to CAPA Engineers
  • Basic Principles of Drug GMP: Meeting FDA Requirements
  • What New Employees Need to Know About GMP Pharmaceutical Regulations and the FDA
  • Drug Enforcement Administration (DEA) Regulations: Basic Principles of Controlled Substances Compliance
  • Drug GMP 21 CFR Part 211 Requirements
    • Subpart B – Organization and Personnel
    • Subpart C – Buildings and Facilities
    • Subpart D – Equipment: Meeting GMP Requirements
    • Subpart E – Control of Components and Drug Product Containers and Closures
    • Subpart F – Production and Process Controls
    • Subpart G – Packaging and Labeling Control
    • Subpart H –Holding and Distribution
    • Subpart I – Laboratory Controls
    • Subpart J – Records and Reports
    • Subpart K – Returned and Salvaged Drug Products
  • Developing and Implementing IQ, OQ and PQ Program
  • Computer Validation Regulatory Documents Explained: The Basics
  • Spreadsheet Validation: Critical Considerations
  • Considerations in Writing More Effective Computer Validation Requirements
  • Establishing and Conducting Effective Drug GMP Audits: Basic Principles
  • Analytical Method Validation – Points to consider
  • Sterilization Process – Validation and Qualification Requirements
  • Cleaning Validation
  • Validation Master Plan
  • CLIA and Clinical Trials
  • Aseptic Processing – Regulatory Considerations
  • Regulatory Challenges in Bioassay Practices
  • How FDA evaluate your quality system
  • How to establish and implement a clinical study
  • FDA Clinical Trials Requirements for Medical Devices

To discuss how Synergy Bioscience can help you, please contact us