How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? Now is the time to evaluate where you stand at this time in the pandemic and make necessary course corrections to prepare for the FDA inspection process to get under full swing.
With the Agency set to begin domestic inspections, there is not much time to evaluate you processes, training records, (remember the pandemic is some 6-7 months old) as well as the qualification of your staff, especially for new employees. Did you need to temporarily suspend or discontinue any processes that could impact the way the Agency views your organization? Did you have to shut down temporarily because of COVID? How diligent were you on restart?
The next big event for FDA compliance staff will be the resuming foreign inspections even though we can only guess when they will start, but will you be prepared? The FDA’s import alert list had grown considerably, and firms are anxious to get their products back onto the U.S. market. In addition, the EU is getting ready to resume on-site inspections as well. So now is the time, while there is still time, to be certain your house is in order. Because once the wolf is at the door, it is too late to take the steps necessary to avoid those 483 observations. We are all in this together and Lachman Consultants stands ready to assist you in preparation for the resumed coming of the FDA. If you need to evaluate your readiness please contact Linda Evans O’Connor at l.evansoconnor@staging.lachmanconsultants.flywheelsites.com.
