Training Services

The backbone of any Quality System is effective training.  Given the wide spectrum of compliance requirements, developing an adequate training program can be a daunting task.  21 CFR 211.25 requires that each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee's functions. Training for current good manufacturing practices shall be conducted by qualified individuals with sufficient frequency to assure employees remain familiar with cGMP requirements applicable to them.

Additionally, each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

CompliaPharm provides comprehensive, tailored training services for both small and large companies. One-time or ongoing training programs are available.  Comprehensive test results for each individual are provided as evidence of training effectiveness. Compliance training is available for:

  • cGMP
  • PDMA
  • Vendor Selection and Qualification
  • Controlled substances (DEA)
  • Supply Chain Compliance (including Cold Chain)

Training is available for all levels of responsibility from the executive level to facility services. Flexible options allow you to have training with minimal disruption to daily activities.  Current training options include:

  • Onsite
    • Small or large groups.
    • Classroom setting allowing personal interaction with the instructor.
  • Online eCourse  
    • Train at your own pace.
    • Access the course material when it is convenient for you.
    • Questions for instructor may be submitted via e-mail.
  • Online Instructor Led
    • Customized for your specific training needs.
    • Allows multiple locations to take the same training simultaneously.