Duration: 75 Minutes
The Webinar will focus on the importance of managing FDA oversight of computer system validation in the pharmaceutical industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment. FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA.
Pharmaceutical companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation. In all cases, pharmaceutical companies should do the right thing and have robust computer system validation programs that are well executed and documented. However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, pharmaceutical companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors.
Typically, a pharmaceutical company will develop a relationship with the FDA office that sends auditors to oversee computer system validation programs in their organization. Depending on upcoming trends, pharmaceutical companies may want to work harder to further strengthen these relationships and build greater trust with FDA to ensure that even as oversight becomes more overbearing, it will not cause the company to waste resources trying to meet expectations that may be unrealistic.
A good example of a recent trend is the focus on risk management in developing, executing and documenting a validation program and validation plans for specific systems at pharmaceutical companies. FDA has fewer resources to conduct audits and oversight of computer system validation, hence pharmaceutical companies have been expected to identify the risk associated with each computer system that “touches” product (through manufacturing, testing, distribution, etc.), and take the appropriate measures to mitigate that risk. The trend has been for FDA to ask questions relevant to risk and ascertain fairly early during an audit what lengths the company has gone to in order to prove they have thoroughly validated their systems accordingly.
Areas Covered in the Session :
Who Should Attend:
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include: