FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.

In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

In this FDA Inspection webinar attendees will learn about the FDA inspection process & the effective techniques how you and others behave and interact with FDA inspectors during an FDA Establishment Inspections.

This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

This webinar will focus on testing as a key element of Computer System Validation (CSV). Attendees will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements. You will also be provided with guidance for maintaining the system in a validated state and assessing the level of any testing that might be required post-validation to ensure that compliance.

This FDA inspection webinar will show you what it means to be “Inspection Ready” and how a Quality System in place at your company will ensure ongoing quality measures to be ready at any time for an audit, review by a Sponsor or any regulatory agency inspection.

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

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 webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.

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.

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

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 webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial 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.