All FDA Regulated Industry
Clinically Proven Nutrition Ingredients – What ACTUALLY Works?
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..
Medical Device MDR following new FDA Guidance
This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include reporting requirements, recordkeeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using form 3500A.Learning ObjectivesMDR regulation, reporting requirements, report timing, when do you..
Production Process Validation: A Short Hitchhiker’s Guide
Process Validation in the Medical Device industry is a a vitally important component of your Quality Management System. While reasonably straightforward in principle, a poor implementation may lead to uncertainty which in the worst case can result in costly field actions. So how do you determine which process to validate and what are the keys to good process validation?In this the session, Mr. Yuval Sha..
Cosmetic Manufacturing, How To Avoid FDA Audits
It is common for personal care product manufacturers to dismiss the importance of applying strong GMP’s to cosmetic product manufacturing. Even the best-run firms are prone to FDA oversite due to shortcomings in their operations. On the scale of FDA regulatory responsibilities, cosmetics are as low as you can go. So why worry? It is easy to forget that all of the regulatory powers given to the FDA under the..
FDA Regulation of Artificial Intelligence/Machine Learning
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..
The Challenges of Virtual Audits...The Developing New Norm
The Quality System Requirements are clear in the expectations for the qualification of our vendors and suppliers required for the products made. Considering the global pandemic, worldwide travel bans, and social distancing, the performance of on-site audits has fallen by the wayside, forcing everyone to establish “virtual” audits. The approach is challenging to the auditor as well as the auditee. This webin..
Sample Size Selection: Is That Number Right?
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..
Analytical Method Validation And Transfer
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..
Best Practices For Auditing A Vendor Of Computer Systems Regulated By FDA
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration, or similar activity. Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a..
Fundamental of Pharmacokinetics
The webinar reviews the general concepts and basic elements of pharmacokinetics. The webinar will describe the processes that a drug undergoes after administration such as the absorption (when not administered intravenously), the distribution, including plasma protein binding, the metabolism (the bio-transformation of the drug into its metabolites), and the excretion (via the bile in faces and via the kidne..
Remote Auditing for FSMA Compliance During COVID-19: Challenges and Opportunities
Food Manufacturing, processing, and distribution are considered critical operations in a crisis, however, the current global pandemic has made it near impossible for food safety professionals and auditors to perform their normal routine inspections and checks. In this the session we will cover the necessity of continued inspection of our Food Chain, how GMP’s and established regulatory measures co..
Drug Supply Chain Security Act Overview
The Drug Supply Chain Security Act (DSCSA) outlines requirements for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers. Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 202..
Technical Writing for the Pharmaceutical Manufacturing Industry
Personnel in Pharmaceutical manufacturing will be asked to review many different documents. These documents are important, in that, they will be scrutinized by regulatory bodies. The aspects of writing these documents are different. The style of writing is more reader-centric, as opposed to writer-centric. Understanding the aspects of reader-centric writing is important in this industry.Areas CoveredThe Pha..
C-TPAT Compliance For FDA Regulated Industries
The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism, primarily by disrupting counterfeit and contraband activity. Becoming a partner in C-TPAT can provide your company with distinct benefits, such as ..
Food Laws and Regulations in Mexico
Processed food and beverages are subject to compliance before Minister Health in MX and other authorities. The numerous laws add complexity in order to successfully explore the marketplace. Counting with the basic knowledge of laws and procedures not only enhances good practices but also guarantees the correct insertion in the market and in the consumer choice.We will be covering the following k..