Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping […]

Understanding the calibration curve

To get an understanding of instrument calibration, we can think of it as being an essential phase in most measurement procedures. The calibration curve is a set of operations with which the relationship between the outputs of the measurement system (for example, the response of an instrument) and the accepted values of the calibration standards […]

Technical file vs design dossier

One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what […]

Supplier quality audit training

Most medical device companies have auditors that assess the quality of the product from the supplier. This is the supplier quality audit. Supplier quality audit training is the training that is needed to be qualified to assess the quality of a product from the supplier. Auditors, regardless of whether they are from inside the organization […]

Supplier qualification program

In the pharmaceutical and life sciences industries, a sound supplier qualification program is a must. It is an indispensable element of their very reputation. Many pharmaceutical organizations contract several of their manufacturing processes or even products to third parties. For this reason, the FDA considers the supplier as a logical extension of the manufacturer. In […]

Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the […]

Process validation for medical devices

The FDA introduced the idea of process validation for medical devices with the idea of improving the quality of pharmaceuticals and medical devices. From its rudimentary form that was conceived in 1987, process validation for medical devices has undergone changes to accommodate more types of devices and more processes into the validation. Why is process […]

Pharmaceutical production batch record review

We can understand pharmaceutical production batch record review as meaning the controls and processes that pharmaceutical organizations have to build into the batch records of pharmaceutical products they manufacture. This is a means to ensuring that products meet compliance standards and are easy to detect whenever a problem arises from a sample in the batch […]

Online compliance training

Compliance training is a vast area of continuing professional education. Professionals in any industry that requires compliance with set standards –this could mean almost any industry or profession –require compliance trainings. Compliance training is required in all these areas, and professional organizations offer these with the help of experts in the field. Online compliance training […]

Medical device quality agreement

In the medical devices, pharmaceutical and life sciences industries, there is a growing tilt towards contract manufacturing. This is done by organizations that perceive benefits in the form of increased ROI and operational ease. In the process of getting these works carried out, organizations have to ensure that their quality and other traits are maintained. […]