Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations...

Overview: Consumer demand for minimally processed products with a longer shelf-life has resulted in the mass production and distribution of chilled convenience RTE foods. However, RTE foods remain a significant vehicle for foodborne pathogens such as Listeria monocytogenes. The challenges are enormous because production of RTE foods frequently involves extensive processing and packaging. Therefore, this webinar is designed to review current kn...

In the calendar year 2015, the pharmaceutical industry witnessed the largest number of Food and Drug Administration (FDA) prescription drug approvals in the past decade. The FDA's Center for Drug Evaluation and Research played a valuable and key role in bringing these drugs to market. With the growth of the pharmaceutical industry, technological advances with the drug screening process and innovative engineering of the drug discovery process,...

Overview: Most entities actively seek maximizing stakeholder return on investments and fostering superior customer relations to sustain creation justification. With information technologies considered indispensable to providing processing efficiency, communication expediency and information reliability for stakeholders; entities need to safeguard adequately information assets because they have measurable value. Management typically requires a...

Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments. Because regulations are legally binding requirements based upon statutory laws and judicial opinions, it is essential that professionals in the pha...

Overview: The ISO 14071 standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also spe...

Overview: This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. T...

Overview: The clinical research community continues to struggle with privacy protections and the subsequent limitations on direct access to electronic health records (EHR) for monitors, auditors and even regulatory authorities. Since these EHRs house the original source data supporting regulatory approvals, some level of source document verification is expected. We'll discuss the risks and benefits of a number of 'alternative' methods being us...

Overview: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include: A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or o...

Overview: Root Cause is an essential component for addressing non-conformance. It uses a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can: Determine what happened. Determine why it happened. Figure out what to do to reduce the likelihood that it will happen again. RCA assumes that systems and events are interrelated. An action in one area triggers an action in another, and another, and so...