FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.

This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.

This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.

This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.

In this Webinar, attendees will learn the winning strategies for successful FDA inspections and as how to conduct robust mock audits during pre-submission and post submission stages of drug product applications. This webinar will also include strategic approaches to implement robust remedial measures to mitigate the potential quality and compliance risks identified during the mock pre-approval inspection in a proactive manner.

This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.

This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.

This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

Learn marketing authorization process for health products in Brazil with focus on documentation, approval process, labeling, advertising, post marketing vigilance. Understand the health protection goals of the law; Polices to meet the applicable regulations. Learn how to harmonize your regulatory strategy for getting approval at less time and cost. How the agency ANVISA works.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

This webinar explains how the ISO 13485 (Medical Devices) & ICH Q10 (Pharmaceuticals) quality manuals create a systematic, formal and collaborative approach for establishing roles, authorities and responsibilities in the planning, development, and implementation of inter-functional cGMP procedures (i.e. Incoming Material Control, Change Control, & Design Control), required by FDA regulations. Particularly applicable are 21 CFR Parts 210-211, Parts 803, 810 & 820, & ICH Q7A. The Quality Manual (QM) synchronizes the law and regulations with quality principles, industry practice, and the writings of “quality gurus”. The organization of the QM’s Table of Contents predicts how well the company understands and practices quality concepts.

This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.