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. […]

Contamination control plan

A contamination control plan is one of the essential practices of cGMP.  Having it in place is a prerequisite for a validated facility, because lack or absence of it is one of the primary reasons for the issuance of 483’s. Among these, the FDA cites lack of sterility assurance as the most important factor for […]

Conducting a clinical laboratory session

For an aspiring clinician, the most important lesson is conducting a clinical laboratory session. What does conducting a clinical laboratory session mean? Lying at the core of health technology programs; a clinical laboratory session is meant to familiarize students of laboratory technology with real life examples of what they get to do when they pursue […]

Understanding clinical compliance

Clinical compliance is a necessary part of a clinician’s profession. Clinical trials are the lifeblood of laboratory experiments and are at the root of drug development. Since clinical trials assume such significance in pharmaceuticals, it is necessary for clinical trials to be compliant with regulations. Regulations are important not only from the perspective of drug […]

cGMP updates

Current Good Manufacturing Practices (cGMP) pertain to regulations that are needed to ensure that the pharmaceutical product or medical devices comply with set standards.  CGMP updates are those updates that the regulatory agency, the FDA, keeps issuing from time to time to keep abreast of the developments that take place in the industry and its […]

CAPA risk management

One of the most commonly quoted, accepted definitions of risk is that it is the probability of harm or hazard in an event. From this definition, it is clear that nearly every clinical action comes with a risk attached to it. CAPA stands for Corrective and Preventive Action. The CAPA-risk management connection The risk an […]

CAPA and risk management

Risk has been often described as the probability of harm or hazard in an event. So, it is to be understood that in the healthcare industry, almost every clinical action has a risk inherent or attendant in it. CAPA, on the other hand, is about corrective and preventive action. From these definitions, we can draw […]

Calibration and qualification in analytical laboratories

Calibration and qualification in analytical laboratories is needed because laboratory equipment should demonstrate suitability for the intended use. The way to do this is by calibrating and qualifying them. Calibration and qualification in analytical laboratories are also necessary because they are subject to FDA inspections. Laboratory equipment is high risk systems Calibration and qualification in […]

Batch manufacturing record in pharmaceutical industry

A batch manufacturing record in pharmaceutical industry is information relating to the product and batch. It is a document that is intended to give a full and authoritative record of the manufacturing history of each batch of every product. The FDA defines a batch thus: “A specific quantity of a drug or other material that […]