Food and Dietary Supplements
Managing an FDA Foreign Inspection
Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..
Managing The Audit Function In A Global Company
Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..
Managing the Transportation of Perishable Food Products
This session is designed for any food industry supply chain players who rely on transportation delivery controls. Air Cargo, trucking, rail, freight forwarders, shippers and others in the food supply chain are key players in the transportation of temperature and humidity-controlled food goods and can benefit financially from offering sanitary and value-added sensor technology to their service packages. The ..
Medical Device Recall Management
Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle a difficult situation. This webinar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and notifications to customers and regulatory bodies.This webinar w..
Medical Device Risk Management Following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post-production risk management program is implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is described in ISO 14971. This is the most powerful of the risk management techniques because it considers ris..
Medical Device Software 62304 Compliance
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device sof..
Modeling and Optimizing Process/Product Behavior using Design of Experiments
Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-at-a-time” trials are often performed. Not only is this approach inefficient, but it also inhibits the ability to understand and model how multip..
Navigating California Prop 65 Incorporating FSMA Preventative Controls, Best Practice Approach
Highlights will include an intro to Preventative Controls, leading into minimal recommended preparation steps for handling Prop 65 requirements, what’s needed to incorporate in your food Safety Plan, focus on hazards or Hazard Analysis Risk Preventative Controls (HARPC), Supply chain Preventative Controls and importance of compliance on Safe Harbor Limits.Areas Covered Details will includ..
Navigating FSMA-Preventative Controls and Key Essentials for Food Safety Plans
Overview of FDA FSMA (Food Safety Modernization Act), a rule which became effective in September 2016 for the food industry. The new regulations have shifted from a reactive FDA focused primarily on GMP’s (Good Manufacturing Practices) to a preventative approach placing responsibility on the food industry to mitigate their potential hazard risks for foods. Highlights will include an intr..
New FDA and EMA Labeling Requirements for Regulated Industries
This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as ..
New ISO14971: 2019 Risk Management Standard for Medical Devices – Implementation
Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis. The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical device products. This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementation..
New National Bioengineered Food Disclosure Act (GMO Food Labeling)
The new rule is highly anticipated by industry and will hopefully bring clarity to the long-standing GMO questions, cover financial and risk impact to businesses as well as helping consumers with educated food choices based on science, in short session encapsulates everything industry needs to know on launching the (NBFDSA).Learning Objectives Background on US GMO (Genetically Modified Organism) LabelingBas..
PK/PD Studies in Drug Discovery and Development
The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation. The use of PK/PD for dose selection during drug development will be described also with the presentation of a case study. The use of PK/PD will be described for the evaluation of both drug efficacy and safety. This will illustrate how the model-based drug development and, in particular, ..
Preventative Controls Approach for California’s Prop 65 for Food Industry
California’s Prop 65 enacted to inform its’ residents and workers the hazards associated chemicals and toxins that may cause harm has ballooned to over 900+ items, that industries must be aware of to operate within the state. The Food Industry has also been subject to Prop 65 legal battles on a host of products including French fries, chocolate, coffee, bakery products, candy and baby food that may now requ..
Proper Documentation and SOPs to Ensure Laboratory Compliance
This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.What laboratory documentation is required for complianceWhat are typical citations as it relates to laboratory documentationWith forethought and design, good procedures are possible Good documentation and record integrity ensure good complianceA..