Live Webinars

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by […]

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 […]

Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the Contract Manufacturing Organization (CMO). CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements and the author’s […]

Risk management is a process that involves the identification of the many considerations, responsibilities, personnel, and the transfer of knowledge. Medical device risk management helps gauge the possible hazards under both normal and fault conditions. It is understood that risk management transcends projects and even companies, thus it is crucial that critical information survive these […]

A critical source of risk to patients using pharmaceuticals to improve their health is inadequate design and control of the processes that manufactured the drugs. R&D, Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs play a critical role in reducing risk associated with poorly operating processes. The ICH guidance documents Q8, Q9 and Q10 has […]

As defined, Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be independent of and separate from routine monitoring or quality control functions. It is paramount to incorporate […]

One of the most impact incentives from the FDA is the Breakthrough Therapy Designation (BTD). It helps in getting the product/drug to market much faster than any other expedited approval pathway. The application processes for Breakthrough Therapy Designation need to request for special meetings with FDA to discuss the development steps, and become eligible for […]

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA. Failure to adequately implement Production and Process Controls (P&PC) can lead to […]

This training on laboratory controls will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to prepare your laboratory for FDA. Many QA and QC personnel in the pharmaceutical industry are not […]