Consulting on GMP cGMP Training and Learning Systems

Our GMP quality management system experts can assist in development of a learning quality system. We can also audit and perform gap assessments to improve their effectiveness and compliance. Based on the identified gaps, Windshire can develop an improvement plan and assist with implementation.

Windshire can also actively assist with development of training material and mentoring of personnel.

Customized GMP cGMP Training

Our passionate trainer work closely with our clients and Windshire subject matter experts to provide customized, on-target and effective training. The customized training can be delivered:

  • On-site
  • Via custom webinars (live or recorded)
  • Live training sessions over the web
  • One on one interactions with our SMEs (e.g., investigations or technical writing)

Customized training can meet the needs of personnel at all levels and take into account your organizational procedures and guidelines. Examples of various levels of training include:

Introductory
  • Basic GMP principles
  • Annual GMP training
  • Basics of microbiology
  • Good documentation practices
  • Aseptic principles and techniques
  • Rounding
Intermediate
  • Managing and hosting inspections
  • Auditing
  • SOP writing
  • Data integrity fundamentals
  • Effective CAPAs
  • Statistical Process Control
  • Principles of Validation
  • Fundamental Statistics
Advanced
  • New regulations and regulatory guidance
  • Advanced root cause analysis
  • Hosting and managing inspections
  • Advanced statistical analysis and sampling

On-the-job (OJT) training

Windshire can assists clients in the creation of role-based curricula and competency-based training that incorporates best practices, and GMP and scientific principles.