FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

IATF 16949:2016 consists of ISO 9001:2015 plus additional requirements for automotive suppliers, and many of these features have universal as opposed to automotive-specific applications. ISO 9001 users can benefit by adding them to their own quality systems as well.

ISO 11135:2014: “Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”, defines the latest requirements for the validation of Ethylene Oxide sterilization of medical devices, the sterilization chamber, and sterilization controls. This webinar will use ISO 11135 as a basis for a field-tested approach to sterilization validation and its documentation, including the chamber control software.

ISO 14971:2019 requires an overall Benefit-Risk Analysis but many companies struggle with constructing the rationale for demonstrating overall benefits outweigh overall risks. This webinar will provide one systematic approach which has proved successful for approaching the analysis.

This webinar will evaluate the chief areas of the Dietary Supplements FDA CGMP compliance requirements as required by in 21 CFR 111, the US Law – this and related regulations mandate a ‘total quality system’ -- from customer requirements thru development, production, to customer use/feedback. Labeling requirements will also be discussed, including those uniquely geared to nutraceuticals. The steps resulting in the present FDA regulatory requirements will be reviewed. This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented) for a neutraceutical company.

Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.

Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

FDA requires that all computer systems used to produce, manage and report data for “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.

Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.

Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.

Recent US FDA Inspections ("audits") indicate the "c" in CGMP is a moving target – with expectations growing upward! In this webinar, learn how to use the FDA's inspection flow charts and questions, past inspections, and key elements of the CGMPs to prepare for an FDA GMP Compliance Inspection. Recognize that past results are not an accurate of future inspection results. You will learn how to incorporate industry findings into your gap analysis and remediation plan.

Today more than ever before the job titles that we hold are not entirely reflective of the work that we do. Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex projects. Project management requires specific knowledge of the key project facets that must be carefully managed. The interactions across divergent corporate functions, culture, language, and time zones all pose unique challenges to the new project manager.

There is a lot of information circulating online about COVID-19 and there is a lot of confusion around what will happen to individuals, what this new enemy is that has suddenly appeared in our midst, interrupted/threatened our lives and what to do to stay safe. The goal of this webinar it to provide clear information to demystify COVID-19 and provide a platform to answer questions. The content is scientific in nature but simplified for people so that people without a strong scientific background can understand the content.

If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.

Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to knowing how to write those documents to properly meet those needs.

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.