Information and guidance on how food manufacturers should handle a serious disaster for interruption of operations, proper cleanup and ramping back processing are not readily available for industry. An important one-stop-shop to guide the process for food processors is detailed in the webinar.The session will explain disaster types, summarize requirements for facilities to keep employees safe and contain th..
Disasters and disruptions of business rarely occur, but if they do they can be costly and dangerous. In R&D, Manufacturing & Retail areas of a food company, there can be dangerous contaminants and other disasters and important data and business processes that could be lost. Every company has a responsibility to their stakeholders (clients, shareholders, employees) and to regulators, to take steps to..
The Quality System Regulations for Medical Device are clear on what the expectations are for medical device manufacturers. However, they don’t provide any input on how to meet the expectations. Many medical device companies struggle to translate the regulations into an effective and efficient quality management system (QMS). This webinar will provide insight on how to create a QMS that is both effective and..
FDA’s regulation of social media operates as a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide an easy common way to cross the FDA’s legal boundaries for “misbranding” your product, whether knowingly or unknowingly. In the end, your firm’s executive management ends up with the legal responsibility for the enforcement action. A regulatory monster lu..
When you receive approval of your product for marketing in the US, your work is not complete. Compliance continues to be an obligation and responsibility of the sponsor (applicant) across all commercial areas. This webinar will provide an overview of the areas of compliance, tasks, tining, and reporting to the Agency. In addition, practical tools and advice for advance planning and implementation of transit..
GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time, the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines ..
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per the US and Europe.Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical prod..
Selectivity in a liquid chromatography (LC) separation is the ability to separate a molecule from other similarly structured compounds, such as conformational, positional, and optical isomers. Columns do this in a variety of ways that depend on the structural differences between the key target molecules. This is most commonly done by tailoring the column’s stationary phase so that the different target molec..
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well written SOPs result in more consistent process output an..
Generic drugs provide an important benefit to patients through reducing drug costs. Developing the generic drug for a marketing application may follow different pathways, and give rise to unique challenges, depending on the active-drug, selected raw materials dosage form, and available bioanalytical methods among others. This webinar will review the basic requirements and steps to be followed for all generi..
FDA’s guidance and regulations have emphasized the use of statistics for many years. Statistical thinking and methods are an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncert..
Food waste is a well-recognized issue throughout the food supply chain. Loss estimates run anywhere from 30% to 50%. Water, fertilizer, manpower, facility overhead costs, delivery/planting/production/storage and delivery, carbon emissions, environmental pollution, and other food production expenses are lost along with the food that cannot be consumed.Food waste, as defined by the U.N.’s Food and Agriculture..
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..
When you sit down to eat lunch or dinner today, like us, most people will check their plate and utensils for cleanliness. Once the food is cleaned, processed and ready for transport, the packaging that carries the food through the supply chain should be sanitized and should protect the food from adulteration. Clean food should be moved in sanitary packaging. No food industry member should package or transpo..
The new standards will be covered in this session encapsulating everything industry needs to know on launching the SFCR.Understanding SFCR and HistoryLicensingPreventative ControlsImportingExportingPortal Overview and ResourcesCompliance Timelines for ImplementationNew Food Safety Regulation to process, import or export foods.Learning ObjectivesBackground on SFCRGuidance ResourcesProvincial TradingForeign S..