FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.
This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.
Although applicable to any laboratory across the world, this webinar will discuss the following as it relates to the operation of a compliant quality control laboratory in a US FDA regulated environment including Regulations and Guidance Overview, SOPs to Ensure Compliance, Types of Procedures, and Electronic Record Keeping.
Traditional process capability studies and statistical control methods rely on the assumption that measurements are available for all items. There are some applications, however, in which the gage or instrument cannot quantify measurements below a lower detection limit (LDL) and returns a measurement of zero (or "not detected"). Typical applications include pollutants, trace impurities, and trace contaminants. Statistical methods for left-censored data can be applied in these cases.
The Medicare/Medicaid Fraud and Abuse Anti-Kickback Statute (the “Statute”) is alive, still with us and as viable as ever. The Statute provides that the offer or payment, as well as the solicitation or receipt, of “any remuneration” in exchange for referrals of any good, facility, service, or item for which payment may be made in whole or in part under Medicare/Medicaid is prohibited.
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
Global clinical trials are increasingly becoming more common for a variety of reasons. While they have many advantages, they come with their own ethical challenges. This webinar’s goal is to act as a forum to discuss the different ethical and moral considerations needed when planning and conducting a clinical trial in a different country.
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
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.
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
This presentation will provide a comprehensive overview of the successful elements of a clinical documentation improvement/integrity (CDI) program. A successful CDI program includes staffing and operational processes that have integrity and are compliance centered.
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.