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...

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application...

Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions. Why Should You Attend:The Toxic Substances Control Act (TSCA) authorizes the EPA to establish rules governing the manufacture, import, processing, distribution, and disposal of chemicals. One section of the act (Section 8e) covers reporting r...

This 1-hour webinar will provide high-level overview of the UK RoHS and REACH obligations effective January 1, 2024 due to Brexit. Key developments and dates will be discussed with an emphasis on the new regulations and systems implemented by the UK. Why Should You Attend: Changes to the UK’s status in the EU presents compliance challenges for companies looking to act in accordance with the laws and directives. This webinar will review t...

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process. Why Should You Attend:Auditing is a critical function within a pharmaceutical or medical device company. Properly performed audits help to ensure that audited parties are operating in accordance with regulatory requirements, procedures, supply/quality agreement...

This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98. Why Should You Attend:Reusable medical devices continue to receive scrutiny from regulatory agencies both in the United States and internationally. Since the advent of ANSI/AAMI ST 98 there has been more clarity in how to perform these validations but it is still...

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF. Why Should You Attend:Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and ma...