6 Tips for Maintaining FDA Compliance – compliance-insight.com

fda-logo#1:  See what is causing FDA Compliance issues with other firms.  Keep on top of FDA observations given to other firms.  Evaluate them for comparison to similar operations in your firm.

#2:  Seek outside help.  Don’t go it alone to be educated or evaluate your FDA Compliance.  Get experts with hands-on experience and knowledge of your particular operations.  Having an outside set of eyes to evaluate your compliance levels or provide training can go a long, long way to improve your quality.

#3:  Think systemically.  Don’t just look at one issue to resolve it – what caused the problem, find the root cause, keep looking and resolve it systemically.    If you don’t heed this valuable tip, then your firm is on a pathway to FDA Non-Compliance.

Read the rest of the article at: http://compliance-insight.com/fda-483-warning-letters/fda-compliance/6-tips-for-maintaining-fda-compliance/


About Karen Delaney

Karen is the President of Helix Consulting Group, a quality assurance company offering businesses a comprehensive range of services to ensure regulatory requirement compliance and assist with approvals and licensing for new product development. With dual Bachelors Degrees in Science and Education from Memorial University, Karen continued to launch her career as an entrepreneur with the founding of Helix Consulting Group. For nearly two decades, Karen has delivered expert Quality Assurance services to a broad spectrum of clientele in Vancouver and internationally. Utilizing her foundation of knowledge and experience, Karen not only provides compliance services, but also extends her talents to assist clients in earning FDA, FAA and TCCA approvals, as well as HC licenses and CE Marking.
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