Training

We know how challenging it can be to train new employees and keep up with the regulatory requirements for ongoing training.  We have developed several training modules under our Pearls of Wisdom Series.  These off-the-shelf basic training sessions help our clients fulfill internal training requirements or fill knowledge gaps. Our staff can also create custom and tailored programs to meet specific education or quality compliance education needs. If our clients require more on the job training, we can provide experienced Quality Advisors to provide on the job training, shadow new employees, or train an internal auditor every step of the way.  We are adept at face-face, self study, and web based training methods.

Below is a sample of courses we have developed.  This is not a comprehensive list, so if you don’t see your topic of interest, just contact us and we can explore your need.

REGULATORY

  • Regulatory 101 – drugs or devices
  • Global regulatory pathways to market – IND/NDA/BLA/IDE/510k/deNovo/PMA & all global counterparts
  • Regulatory filing requirements for drugs vs. biologics vs. devices
  • Requirements for an IND or IDE submission
  • Managing the development and regulatory challenges of companion diagnostics and therapeutics

QUALITY COMPLIANCE

  • GMP training – beginner and advanced
  • GCP for sites/sponsors
  • GCP training for Principal Investigators and staff
  • IRB and human subject protection – beginner and advanced
  • GLP primer
  • Steps to building a flexible quality system
  • How to build a CAPA system that works for you
  • Supply chain/third party vendor management best practices
  • Preparing for FDA audit/inspection
  • PAI and BIMO inspection readiness
  • Responding to 483s and warning letters
  • Quality system requirements for compounding pharmacies
  • Quality system requirements for dietary supplements

CLINICAL

  • GCP for sites/sponsors
  • GCP training for Principal Investigators and staff
  • IRB and human subject protection – beginner and advanced
  • Preparing for BIMO or PAI readiness inspections
  • Quality system requirements for research sites
  • Responding to 483s and warning letters