Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

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.

This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

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 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.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Everyone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.

Attend this webinar to learn how to translate a new guidance or regulation into a working process, and how to use process flow, techniques and templates to develop procedures on your own. The webinar will provide you with a working SOP for Risk Management.

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments. There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

This webinar will discuss the causes for failure in our deviation systems and recommendations to successfully take a different approach that results in problems finally being solved.

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

This webinar will discuss the recent attention regulators have placed on data integrity and show how the requirements are not new. The sources of data issues go far beyond the laboratory and are not just found in computer/electronic systems.

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.