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.
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.
In this webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described. Attendees will Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.
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 webinar sheds light into the European generic market, its regulatory procedures and the effect of the differing national pricing and healthcare environments that have moulded the markets in individual countries.
This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.
This webinar will help you better understand test method validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.
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 training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to re-engineer a case management department and tips for identifying the best model for your organization.