Cleaning and Sanitation Training for Food Processors

We will cover several topics of value to food manufacturing sanitation team members. We will begin with a conceptual understanding of cleaning vs. sanitation. We will then review proper cleaning techniques to ensure microbial and allergen residue removal. Attendees will learn about the chemicals used in industrial cleaning and sanitation and how to protect themselves […]

Best Practices in Vendor Risk and Compliance Management

Best practices in vendor risk and compliance management need to be inculcated by vendors who deal with them because of the enormous risk their activities carry. Implementation of best practices in vendor risk and compliance management goes a long way in checking risks and with it, the adverse fallouts of a vendor management program. First […]

Quality Risk Management in the FDA-Regulated Industry

Quality risk management in the FDA-regulated industry is a vital area of regulation for the FDA. Risks to quality may arise from many sources. The FDA has entrusted itself with the responsibility of making sure that the quality of the products it regulates is maintained through a due process. Quality risk management in the FDA-regulated […]

What is logistics and supply chain management?

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed. Logistics and supply chain management is emerging as a […]

Risk Management and Compliance in the Healthcare Industry

Risk management and compliance in the healthcare industry requires a high degree of foresight, observation and knowledge of the regulatory rules and principles. Apart from being aware of the regulations, risk management and compliance in the healthcare industry is a lot about being smart, inventive and observative about the day-to-day aspects of the workings of […]

What are the potential areas of risk management?

  The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark. In a very broad sense, the potential areas of […]

6 Ways To Start Improving Your Gut Health Today

Brooke Lark / Unsplash Considering the rapid rise in kombucha, sauerkraut and probiotic products, it’s pretty clear gut health is on everyone’s minds. And with good reason — more and more research is emerging showing just how important good gut health is for overall wellbeing. “Having a healthy gut is so important,” accredited practising dietitian […]

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). There are three types of Premarket Notification 510(K)’s that may be submitted […]

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. Although these new guidelines appear to remove the need to follow GMPs for […]

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right. FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, […]