All FDA Regulated Industry
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenteral and medical devices. Sinc..
Medical Device Complaints and Corrective and Preventative Action (CAPA)
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is str..
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..
Medical Device Software Validation that Meets FDA Requirements
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis invalidation. How software requirements are developed and used in validation will be described.Learning ObjectivesSoftware validation is more than testingRequirements traceabilityRisk analysisUnit,..
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 Federal Regulations Affect Healthcare Providers and Amateur Radio
The Webinar will center on: Introduction to Centers for Medicare & Medicaid Service regulations (CMS.gov), vulnerabilities facing medical facilities, businesses, and emergency communications provided by Amateur Radio.Amateur Radio’s primary purpose for existing is to provide backup communications in times of disaster. The webinar presents methods used to provide communications when Internet and Phone Sy..
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..
Onboarding in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.Although FDA expectation..
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, ..