Food and Dietary Supplements
Navigating California Prop 65 During COVID While Incorporating FSMA Preventative Controls, Best Practice Approach
This session will detail the history, process, and unique CA OEHHA system for compliance and warning labeling for consumers. Additionally, we will cover all the changes since the COVID crisis hit the state and how 60 Day notices are proceeding. Also, we will cover pending cases, proposed labeling changes, and most importantly, how to navigate compliance within existing FSMA best practice preventative cont..
In 1994, Congress passed the Dietary Supplement Health & Education Act (DSHEA) which changed the health food and dietary supplement industry forever. Unfortunately, lack of enforcement and inconsistent rulings have caused countless companies headaches when deciding on new product formulations. Join us to gain a true understanding of what DSHEA is, why it was created, what compounds can be used without f..
Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..
An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to what caused the non-compliance?The records in a lab – the logbooks for chemicals, reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks – all are ..
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH, and USP have each recognized the importance of th..
AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following de..
Guidance For Industry - Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) Of The Federal Food, Drug, and Cosmetic Act
On December 23, 2019, the Food and Drug Administration (FDA) issued a proposed rule and draft guidance to facilitate the legal importation of certain drugs, which the FDA and the Department of Health and Human Services (HHS) first described in a July 31, 2019, Safe Importation Action Plan. The Safe Importation Action Plan (SIP) introduces two possible pathways for such importation.FDA has issued the GUI – I..
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a produc..
This webinar will introduce and overview the concept of containing compliance costs – working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. These strategies include Regulatory Documentation – Regulatory documentation is the most visible aspect of regulato..
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls, and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impac..
The requirement for qualifying suppliers, as part of the Quality System Requirements covering the supply chain for companies, is one that presents significant challenges to the industry. The challenges include the number of suppliers to qualify, the risk to product quality that each represents, and the resources and cost to manage the program. This webinar will look at the basics of establishing a compliant..
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production a..
The current pandemic has turned the global focus on the issues surrounding the patenting and protection of COVID-19 vaccines, drugs, and other treatments. On the one hand, companies and institutions developing these treatments want to protect their innovations. Like other patent claims, compound, composition, and method claims for vaccines must have a novel, non-obvious, and useful properties. They may also..
This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions, and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer-term projects and ensure they stay on track. Learning ObjectivesDiscuss what to do when problems occurOutline the requirements of the CAPA process a..
Creating an effective dietary supplement takes more than simply mixing the most popular or “hyped up” ingredients on the market. Over the years we’ve seen ingredients receive unbelievable popularity only to be disproven by science not long after. Join us to see which ingredients have powerful clinical evidence, the potential structure-function claims that these compounds can provide your product, and see wh..