FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to […]

Technology transfer in pharmaceuticals seems complex or simple based on who is looking at it. For site manufacturing team, it may be complex as they’ve to do go through a series of processes before they can term a transfer to be successful. For transferring site or R&D it may be a simple activity as they […]

Corrective and Preventive Action (CAPA) plays a central role in quality management systems. Its customer and supplier processes include far more than just control of non-conformances; they also include customer feedback, audit findings, the management review, and even more. Inadequate CAPA is a predominant source of ISO 9001 and IATF 16949 audit findings, and FDA […]

ISO 13485 is the international quality management system standard for medical devices. The function of this standard is to “specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.” The standard has its beginnings in […]

Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results for pharmaceutical, cosmetic, Vitamins, minerals and supplements and medical […]

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compliance with regulatory agency requirements. Still, their importance is often underestimated, especially in the planning phases, which leads […]

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Areas Covered in the Session : Overview of Change Control Regulatory Requirements What […]

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You must follow best practices for developing a validation program that includes planning, […]

IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 —  Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Its 9 Stages provide a repeatable process for performing UE and […]

The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its intended use and is safe to patients, consumers, and health professionals. Regulatory submissions that are poorly […]