This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
This webinar will discuss how to use tiered approaches to evaluate the benefits and risks of novel nanomaterials and product formulations containing nanomaterials, as well as common risk mitigation approaches.
Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
This webinar will provide an introduction to FDA rules governing manufacturing, testing, labeling and marketing of pet food in the U.S. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.
Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.
This training will prepare hearing officer for corrective actions and how to prepare for the hearing. It will cover application process for new applicants which include prior practice, references, prior adverse actions and liability settlements. Attendees will learn elements of good, clear and concise bylaws, fair hearing plans and other policies.
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
Use of customer testimonials, reviews, or endorsements in the advertising of dietary supplement products can be considered “commercial speech”, depending on how and where it is used. It is the responsibility of your organization to ensure use of this content in the promotion and advertising of products is not only used with permission, but is also accurate and compliant with FDA and FTC regulations. This webinar discusses important regulatory considerations when incorporating user-generated content in the advertising of dietary supplements.
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.
Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations. To meet these standards, the FTC has stated that claims must be substantiated by “competent and reliable scientific evidence.” This course provides strategies to: 1) identify claims; 2) characterize/rank claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.
This healthcare coding webinar will provide an overview of ICD-10-CM, the format and guidelines. It will also explain the differences between ICD-9 and ICD-10 to help you understand how it will affect your work and as well as your co-workers and providers.
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.
