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...

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 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...

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). Why Should You Attend:This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how...

Review a company's calibration, verification, and validation system against the critical requirements of the CGMPs and risk management. Starting with the required but often neglected Master Validation Plan, evaluating ISO 14971 and ICH Q9 risk analysis and documentation requirements in hazard analysis and product risk management, and a solid calibration program allows the development of meaningful product quality-specific equipment validations...

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP lifetime. Why Should You Attend:Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs...