Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

Change Management is one of the most critical quality systems a company can have. Well managed systems are effective in implementing desired changes and preventing unwanted modifications to validated processes. This webinar will discuss the requirements for change management, the steps for effective change management and the actions companies can take to ensure unwanted changes do not occur in their operations.

Accurate measurement of weight and correct use of volumetric apparatus are prerequisites for valid analytical measurement. This webinar covers the quality-critical aspects of both. It is intended for new starters in industrial analytical laboratories or for other staff who would benefit from refresher training.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

In this webinar the presenter will draw upon his experience in starting new private, contract research, state and federal government laboratories and laboratory subdivisions to elaborate the numerous aspects of developing a plan to open a new analytical lab for business in a reasonable amount of time.

This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

QA groups in the pre-clinical space need to be the driver of change and improvement in their organization. In the coming decade the reliance on management to be a driver of change is no longer a held value. Senior management is looking to QA to be to set the tone for the organization and be the champion of the changing regulatory environment.

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.

This webinar will present and apply FBI, FDA and EPA approved methods for the determination of limits of detection (LOD) and limits of quantitation (LOQ) in chemical forensic and environmental analysis. These methods apply to most analytical techniques including gas and liquid chromatography, mass spectrometry, and elemental and molecular spectroscopy and can be used when analyzing blood, urine, food, or trace evidence for the presence of toxic chemicals or drugs.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This webinar will present approaches to instrument calibration that are used by FBI, FDA and EPA in forensic and environmental analysis. It will emphasize the importance of calibration in obtaining accurate results in analysis of trace evidence, toxicological specimens and environmental samples.

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.