Posts Tagged 510K
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on May 16, 2013
Connie Hoy, VP of Regulatory Affairs at Cutera, shared detailed preparation plan to follow during the two weeks prior to the FDA audit at www.bio2devicegroup.org event.
“Hello, it’s the FDA”, this simple phone call can start a frenzy of preparation for a life science company’s next scheduled inspection. There will be less panic, with better prep. Hoy said, your overarching goal should be to get the auditor out of your facility in the shortest time possible. Their presence is disruptive, stressful, and debilitating to the functionality. Here is a step by step guide to prepare for the audit methodically, so they can come, get their job done, and leave.
Hoy suggested, first inquire and understand if it is routine audit or QSIT. While a routine audit is broader, in QSIT audit they would focus on 4 main aspects pertaining to quality systems, but frequently it also can end up being broader. Ask if it is a follow up audit resulting from the complaint letter, if it is a factory audit for PMA, or if it is a CDRH audit. CDRH audit pertains to ultra scans, lasers, x-rays, MRI and catscan machines. Understanding the focus of the audit, is the first step in preparation.
Next, get to know your auditor. Take down the name of the inspector and email and other contact information. You can also go to fdazilla.com and learn more about the inspector, see the kinds of warning letters issued by them, and understand what kinds of things they are more likely to focus on. An inspector with engineering background can likely focus more on design control and one with an MD under the belt, can focus more on clinical trials, and so on. You can also call your friends and ask anything more they can share about the inspector. Finally, you can look up blogs with RAPS members (new warning letters get posted every Tuesday after 9 am PST).
Immediately inform executive management and the directors and managers in the company, about the upcoming audit. Everyone should know about basic quality policy pertaining to their job, and they should be instructed to tell the truth. Everyone should be able to answer the question, how do they know what is required of them in their job, by pointing out that it is defined in the job description, told through instructions, by following appropriate procedures, and knowing how to access procedures and instructions. Regardless of how small a piece of work they do, for instance, tightening screws, they should know where the product ends up and how it impacts the patients.
Guess the upcoming auditor’s schedule and plan accordingly. Plan for an opening meeting with the executive team, arrange a factory tour, focus on corrections and removals, complaints, AE, MDR, CAPA, management review, and review of previous 483 corrective actions. Plan for auditor’s arrival from the moment they step into the office. The receptionist should sit the inspector and call management representative immediately. Prior to the arrival of the auditor, remove every single piece of product literature from the lobby. Plan where the auditor will be seated and keep them close to the document control, to coffee, and to the restroom. Set up all the necessary one on one meetings with key employees, after considering carefully if they have been audited before, they know what to expect, and their fears and questions are addressed. Remind them to read their SOPs and give them your cell phone no. so they can call with any last minute questions and are not stressed out.
After the auditor arrives, make a short presentation that explains the business, the products, history of the company, how long the company is in the market, where are the head quarters, where is the manufacturing done, which employees are directly involved with product line, show organizational chart of the management team with names, RA/QA structure of the department, information about annual sales etc. Also, prepare and give product chart, product names, technology, 510K status, date etc. and hand out on-label product brochures. Use flow charts in SOPs. With this upfront information, you could save hours that they would otherwise spend asking you questions. You can also ask them prior to arrival, if you can send some information they can look at in advance. Remember that the auditor may not be an expert in your field. They might have audited cheese, cat food, mascara, and more, in the last month. Explain your products in clear, non technical way. Patent brochures may be good to hand out as well. Ask them if they prefer to receive electronic records or on paper. Make sure the room is set up with access to network, projector, and printer. Ensure that there is a backup and a runner. The goal is to have them spend as short an amount of time as possible, at the company site. With through preparation, ” you can then relax and your FDA audit may not be a panic driven event”, said Hoy.