This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers. Areas Covered in the Webinar:Regulatory Requirements for Quality AgreementsDefining the Purpose of Quality AgreementsDifferent Types of Qualit...

Processing ACH Reclamations from the Federal Government can be challenging! Chapter 5 of the Green Book has been updated making it mandatory for Financial Institutions to respond to all reclamations must be submitted through the Automated Reclamation Processing System (ARPS) located in Treasury’s Pay.gov web portal (except for responses by DFAS and any Treasury-approved exceptions). The Nacha Operating Rules still apply when processing t...

Performing a corporate wide risk assessment is doable, and can provide internal audit and its organization a roadmap for the upcoming audit year. In this webinar, participants will learn how to maximize the time spent on the risk assessment process on an annual basis. Why Should You Attend:Performing a corporate wide risk assessment can seem like a daunting task for an organization. In reality, it can be done using a template and brainstorming...

This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2024. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms. Why Should You Attend:REACH and RoHS have been referred to as "…two of the most complex regulations in the history of the EU." They present compliance challenges for...

This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation wil...

China’s Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China’s NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products. Why Should You Attend:China has been improving its’ regulatory regime governing the food and pharmaceutical industry in recent years. By promulgating the amended GMP and amending GLP, GCP, GSP and other regulati...

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits. Why Should You Attend:There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual comp...

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations. Why Should You Attend:This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced bac...

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system. Why Should You Attend:An effective change control system is one of the cornerstones of a productive organizational quality system. Change control can be instrumental in ensuring continuous contro...