Laboratory Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss the use of records to identify root causes of non-compliance in GLP or ISO 17025 compliant laboratory.

This webinar will focus on the USP and FDA requirements for qualification of the dissolution apparatus including guidelines for USP Performance Verification Test and FDA Advanced Mechanical Calibration. It will also provide an overview of USP General Chapters <1058> and <711>.

This webinar will cover in detail the regulatory requirements of Clinical Laboratory Improvement Amendments (CLIA). It will also discuss major lab quality standards such as facility administration, general laboratory systems, personnel qualifications & responsibilities, proficiency testing and more.

This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.

This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.

This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.