Now that you have compliance, how do you maintain (or improve) it? Here are 6 Tips For Maintaining FDA Compliance:
#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.
#4: Keep it simple. Complexity only adds to the resistance that people have to follow procedures. Simple instructions, simple procedures and pictures will aid greatly the capability of your firm to meet FDA requirements.
#5: Don’t settle for mediocrity. When performing tasks – no matter how minor or significant, do it with the determination that you are performing Quality Work.
#6: Be open minded that there are several paths to FDA Compliance. For some instances, a single option is required, however, more often than not, there are several ways to get from Point A to Point B. Having people with experience (see Tip #2) goes a long way to give you a true picture of your choices.
Free FDA 483 Action Package
Compliance Insight has created a free FDA 483 Action Package to help you respond to a FDA 483. Click the button below to learn more and download you copy today.