FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is aimed at prevention of contamination, instead of end-product evaluation.

Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and well fare of your customer base, which actually is the entire U.S. population. In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.

This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.

Although there are no official regs for cosmetic GMP’s, failure to maintain control of your operation can lead to severe regulatory consequences. You can avoid unwanted FDA oversight by maintaining cosmetic processes under control. One avoidable recall could result in a domino effect having tremendous negative impact on your organization.

This course for pharmaceutical professionals provides the information they require, to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI).

This webinar will discuss handling situations where training has been identified as a root cause during an investigation. Rather than prescribing the all too common, and largely ineffective, re-training event, discover quick and powerful ways to get at what influenced the individual, and how to address these underlying factors to more effectively prevent recurrence.

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar will help you create an inspection readiness plan so you are well prepared for an FDA inspection. This webinar can help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

This webinar will illustrate a set of unique tools that simultaneously address challenges of improving awareness, accessibility and compliance with process-related information. Learn how to construct solutions that people across your organization can use to better understand how processes work and how their role fits in, all in ways that complement your existing procedures and document structure. You may also find these tools useful when performing investigations, identifying and mitigating potential risks, and describing a process to a regulatory inspector.