Sometimes we get emails from people who are just starting out in the field of regulatory, quality, and compliance, asking us – what advice do we have for new people to get onto the right path?
I turned to you on LinkedIn, and these are some of my favorite responses:
- It basically comes down to this.., have an approved procedure.., say what you do.., do what you say. It is not always convenient, but if you follow that practice, you will avoid most 483s. – John LaMascus
- I would recommend developing a complete understanding of the expectations of the various regulatory bodies and developing a good working relationship with them. – Robert Coleman
- Have a history lesson – learn from the mistakes of others. FDA has this all tabled out: http://www.fda.gov/ICECI/Inspections/ucm250720.htm. Even if you just work on the top 7, it would be already awesome, because if you look at the past few years’ data, that top 7 hasn’t changed too much. this way you won’t be easily blindsided during the inspection. That is in assumption that you already have a completed QMS to begin with. -Ee Bin Liew
- Re: SOPS, it is crucial to have the right amount of detail. Too little and the document fails to provide necessary instruction — too much detail and the risk of “failure to comply” with your own requirements soars. – Jane Norris
- Do not volunteer information. Answer each question exactly as it is posed, even repeating the question so you can hear the words again before responding. – Jane Norris
- If there is an incident or an aspect of your processes that would be deeply awkward/embarrassing to explain to a regulatory agency, assume they will ask you about it and work on resolving it. -Bruce Gardner
- FDA 483s , understand why that is given to a organization, understand who are you and your organization ultimately serves, i.e Patient, or someone who depends on you and your organization to “DO THE RIGHT” thing, if you put yourself in the “Customers” shoes , you will start seeing all why all these “Regulations” are there, remember these regulations are there because someone could not “Read” and “Understand ” what needs to be done to assure “Quality” and “Efficacy” of your product. -Simhan Mandyam
- Do what you write, write what you do. -Priyanka Chawla
- Preparation, preparation and preparation !!!. Have joint periodic walkthru (QA and Production) correct every single deficiency noted (don’t argue if this becomes a 483 item or not). Prepare a gap assessment of your process and testing. Identify potential gaps and close them adequately. Prepare list of hot topics that are likley to come up, have SMEs lined up to speak and subject them to rehearsals.Have list of deviations, OOSs, change controls, number of lots manufactured and rejected (with reason for rejection) for the past one and two year periods. Review these information. Do not spend too much time to get some standard requests that FDA investigators make on the first day of the inspection. Prepare a training module on inspectional behaviors and inspection process. Train all employees prior to the inspection. – Ramadas Bhat
- All of the prior comments are excellent. I would add ALCOA & document in real time so that you are unlikely to miss documenting an event accurately. -George Gasparis
What would you say to someone just getting started in the industry?
Other FDA Inspection resources: