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...

As payments continue to evolve, so does the ACH Network. In an effort to continually update the Nacha Operating Rules, Nacha had put out a RFC (Request for Comment) on adding a fourth window of opportunity for SDA (Same Day ACH) payments to allow more functionality with Same Day payments in all time zones. Description:There are two (2) Operations Bulletins released in Oct and Dec 2024; the first one being ACH Operations Bulletin #3-2024-Open B...

Standard Operating Procedures (SOPs) are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you wil...

This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover. Why Should You Attend: An audit manual is essential for adequate documentation and to ensure that th...

This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs). Why Should You Attend:Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ev...