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 […]

GSK therapy for multiple myeloma receives breakthrough therapy designation

The Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline (GSK) for its investigational B-cell mutation agent (BCMA) monoclonal antibody-drug conjugate, GSK2857916, for relapsed and refractory multiple myeloma. Expand This investigational therapy has also been granted PRIME designation from the European Medicines Agency (EMA) back in October for the treatment of relapsed […]

The use of Applied Statistics for FDA Process Validation

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA […]

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 […]

Article on “A Tour of the FDA”

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA […]

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, […]

cGMP updates

Current Good Manufacturing Practices (cGMP) pertain to regulations that are needed to ensure that the pharmaceutical product or medical devices comply with set standards.  CGMP updates are those updates that the regulatory agency, the FDA, keeps issuing from time to time to keep abreast of the developments that take place in the industry and its […]