Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management. Every associate within the organization is responsible for being compliant and having the skill and knowledge to properly interact with inspectors and manage the inspection process. This virtual seminar will […]

In this training program, attendees will learn how to write a factual, solid, representative report of an internal investigation that will withstand scrutiny and provide appropriate information to decision makers. Since reports are often read by adversaries as well as not only internally within the organization, it’s important that reports as an overview of the […]

This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union’s MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents’ differing purposes / goals, as […]

Residual impurities resulting from the synthetic route, the formulation, or from the degradation of the active drug and/or the excipients, may be present in the pharmaceutical products that will be administered to patients. Some of these impurities may present a potential for genotoxicity and therefore pose an additional safety concern to clinical subjects and patients. […]

Inspection is a necessary but non-value-adding activity whose purpose is to protect the customer from poor quality. We should therefore do as little as possible, upon condition that our inspection plan meet the customer’s requirement. Inspection plans with acceptance numbers of zero (c=0) minimize the sample size, albeit at the cost of a higher producer’s […]

This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report […]

Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to […]

This 3-Hour virtual seminar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. It will also address how human error occurs in the planning and execution stages of […]

This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be […]

This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be […]