FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.

The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

This course provides 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 will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products.
The focus of this webinar is on providing the information needed for attendees to understand the concepts of risk in relation to process validation and to be able to compute sample sizes and lot sizes according the desired or required specification criteria or the process or product.

This webinar provides an overview of FDA’s requirements for vendor management and oversight for pharmaceuticals, biologicals, and medical devices.

This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.
The course examines actual situations, guiding participants in effective investigation resolution and determining solutions to effect proper corrective action.

This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.

Many of the commonly used statistical tests and calculations of chart limits (or other measurements) require that the data be “normally distributed”. This webinar will show you how to check for normality in your data and apply transformations to non-normal data. You will also learn tools and concepts to understand when a transformation of data is, or is not, necessary.

This webinar will discuss the steps to perform a good fact-based investigation, tools, and when to use them for analyzing facts gathered during investigation to identify one or more root causes and Tools for determining appropriate actions to take to address identified root cause(s).