You have just been the Chief Compliance Officer at Company A for less than a week and FDA informs you that they plan to audit your company and the clinical sites that your company have been collaborating with on a multi-center study in the U.S for GCP compliance. The FDA audit will take place in 3 months.
(1) What are your Company As strategies to deal with this FDAs inspection for GCP compliance? Please explain in details and cite specific relevant regulations and/or guidances.
Preparedness to deal with FDA inspection is one of the key practices in any company under legal obligation to be inspected by the FDA. As a chief compliance officer, it is paramount to ensure that the company passes the tests by the FDA as failure to do so may not only affect licensing of the company, but may go as far as affecting marketability of goods provided, which may even negatively impact share prices. Basically, an inspection strategy is required which may involve mock inspections. This strategy involves a plan that is executed, assessed and continuously improved upon.
First off, it should be ensured that an inspection room and a control room is set up in various inspection sites for company A. This would ensure that information would be available to the inspectors on demand. In the case of the inspection room, we have a room filled with all the documents that the company perceives that the inspector is interested in. Thus, the inspectors have the opportunity to look through the documents in addition to their area survey. This makes it very convenient for the company and gives off an air of openness to the inspectors. To supplement the inspection room, a control room should be setup having database records with access to all conceivable documentation of the company and having a printing device and basic office instruments. Therefore, any other information required by the inspectors can be easily accessed by use of runners who provide an interlink between the two rooms.
Another strategy would be the provision of relevant information to workers. Ensuring that workers have the relevant information in their hand and know how to respond to questions is the key. The inspection and control room teams should especially be empowered. Employees should also practice on type of questions that the inspectors commonly ask. In short, the employees should be trained to focus on the question asked, know how to admit to lack of knowledge of a specific answer, create an environment that enhances positive aspects but at the same time brings up the desire to take positive criticism and finally all employees should at least have basic training on the ensuring of quality standards.
Carrying out mock inspections (internal audits) and practicing of the inspection process is the best way to ensure that the company meets the quality standards. Mock inspections ensure that employees are well versant with the inspection process and are able to provide satisfactory responses. Repetitive internal audits also ensure that any flaws in quality is identified and dealt with as necessary.
(2) How do you plan to prepare the clinical investigators and their staff for this FDA inspection? What documents would you want to review? Who do you want to interview at the clinical sites? Do you foresee any potential problems that need to be addressed immediately? Please explain and cite relevant regulations and/or guidances.
In preparing for the FDA inspection, it is important to ensure that specific activities are carried out to ensure that the clinical investigators have ample resource to inspect the premise. First, one should get the details of the FDA personnel visiting is acquired. This includes the full name, title and contact information.
A schedule for the exact date should also be set up with the FDA. In this case, in should be within the minimum lead time which is ten days in the case of the USFDA. However, the lead time can be shorter or longer depending in the FDA workload, the inspector and other administration factors.
It is also important to notify all sponsors and principal investigators on the occurrence of the inspection. Thus, key stakeholders have prior information on the occurrence of an inspection. Next, it is important to ensure that all record forms are available and that signed informed consent forms are available for every sector that will be inspected to ensure smooth flow of the process.
Staff who were involved in collecting of the data normally used in collection of the data comprising of the documents and PIs should review the aforementioned data in detail. Thus, they should revise the protocols that took place in collection of the data and who, how and where it was collected hence refreshing their familiarity with the data.
Finally, it is important to review inconveniences carried out by the previous QA audits and ensure that corrections are carried out based on the same. In conclusion, it is also important to review the documents that FDA have legal access to which includes all records apart from financial data and information, sales data except shipping figures, pricing information, personnel records except training Records research data except for product being inspected and all personal records.
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