Our Industry’s GMP Training Dilemma
Training deficiencies represent an increasing percentage of the citations issued by FDA each year. For example, from 2005 to 2008, the percentage of warning letters citing training violations increased steadily from 17% to 30%.
“…No matter how effective quality assurance and production systems are as concepts, people still play a major role in designing and producing a quality product. Lack of training — as reflected in instances of negligence, poor operating techniques, or the inability of employees to discharge their functions properly — can lead to defective products and, sometimes, to regulatory or liability problems…”
— U.S. Food and Drug Administration
ComplianceAcuity Training Solutions
- Onsite or webinar-based GMP training seminars:
ComplianceAcuity’s Principal Consultant Kevin Randall routinely provides FDA QS/GMP training to medical device companies, including programs run in collaboration and participation with the U.S. FDA. Recent attendees have included CEO’s, design engineers, production operators, and of course RA/QA staff. Here are some of the reviews ComplianceAcuity received:
- Standard Operating Procedures to help you satisfy 21 CFR 820.25 and ISO 13485:2016 clause 6.2, including gold-standard training features such as:
- Job descriptions to intelligently guide training plans.
- Guidance on employee selection and hiring.
- Training needs systematically assessed and documented.
- Turnkey forms and templates to facilitate new-hire training, job-specific training, and refresher training.
- Methods for checking training effectiveness
"...I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed t...