Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

The online training will offer food manufacturers a 360 degree approach to food nutritional labeling from a past, present, and future perspective.

This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®.

This training program will clearly define all requirements of the Toxic Substance Control Act (TSCA). It will discuss best practices for developing TSCA written plans and TSCA training plans, as well as breakdown all components of the TSCA.

Lean implementation is not confined to just manufacturing. It can be appropriately applied throughout the organization in all functions. This virtual training program, however, focuses on manufacturing, where lean was born. The difference between this treatment of lean application and others is that we have imbedded the concept of GMP and compliance into our lean model to make it particularly applicable to the life sciences.

This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.

This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.

This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.

Learn how the FMEA and control plan can be combined to create a dynamic control plan, a living document that helps to drive continual improvement.

This webinar will cover creating of a value-added an internal and supplier auditing program for compliance to FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, as well as how to conduct audits, and document the results and any nonconformities. It will discuss the value of a good auditing program.

Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.

The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.

FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

This course will review the basic requirements of pet food nutritional labeling, including the eight required items all pet food labels must have and the agencies that define and enforce the rules. The course will also cover frequently asked questions within the industry including guaranteed analysis and calculating calorie content. For pet food manufacturers wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.

Lean is not a quick fix for doing more with less and doing it in half the time – it is not something you undertake to realize short-term improvements – it is on the other hand, a new way of thinking about your business and a new way of executing business activities. This virtual training and the others in the series will lead you through the journey of lean from its inception through complete implementation.