FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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 training program 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. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

This webinar will discuss in detail Process Reliability Modeling (PRM) method including its history, the process, validation, and results of effective management, sigma score and customer satisfaction. Attendees will learn how to convert qualitative information into quantitative data to determine process and system reliability.

This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

This webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.

This training program will assist 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. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.