FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

This webinar will provide you a thorough background into the FDA regulatory and EU control issue related to the specific device required to provide expert opinions.

The FDA’s emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers. So, it is critically important for companies throughout the life sciences and healthcare industries that utilize software in its products to understand the important challenges and opportunities presented by this major policy shift. This webinar will provide understanding.

This four day webinar series (each day 3 hrs) will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.

In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.

Attend this webinar to learn about the Brazilian pharmacovigilance regulation, risk management, the Health Brazilian Constitution Rights. Learn about labeling, safety reports, harmonization process, benefit-risk legal concept, reciprocity, and more.

If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. Knowing what makes FDA employees the way they are, will help immensely in understanding how to deal with FDA.

This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.

This course will discuss the various steps associated with the EM program from the Phases, through Validation, Implementation, Procedural Steps, Documentation Practices, Data Management, Trending of Data, EM Excursion and the relationship of the cleanroom state of control and product impact and analysis.

This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.

This seminar will explore the unique and critical relationship between regulatory compliance, compliance documentation, and technical operations training and improved performance, standardization and world class regulatory compliance. We will also discuss the area of training in regulated environments, its importance, and its relationship to compliance documentation.

This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.

In this webinar, we will review in detail major considerations to be well-thought-out during the prescription drug product development process. We will review in depth FDA cGMPs and their importance in drug manufacturing. We will review the submission process and post-approval commitments. This webinar is Part 2 of a 2 Part series.

This webinar will review in depth FDA and other important US Regulatory Bodies roles and responsibilities pertaining to the prescription drug development process. We will explore the recognized regulatory approval pathways, good clinical practice and clinical study concerns.

Attend this webinar to get an overview of the recent Brazilian changes regarding the big data protection in Regulatory Affairs. It is an opportunity to analyze and discuss key issues related to the data protection applicable to all medical, pharmaceutical, food and cosmetic product.

Attend this webinar to learn the logical, fast and simple process of how to easily write any document that your company requires. Explore how to organize collected information, write the document and address the comments from reviewers and approvers.

This Webinar is geared toward those who require a working knowledge of biocompatibility.

This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.