Overview:In this webinar speaker will discuss the best practices necessary to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program. Why should you Attend:Those users accessing the business system must also not be able to enter or alter data directly into the laboratory system, unless it is clearly a requirement based on the process being followed. Areas Covered in the Session:...

Overview:This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logistics operations and to provide you with some of the tools needed to meet new regulations and customer demands. Why should you Attend:You must prepare your perishable transportation processes to meet new FDA FSMA rules requirements. Take a walk around your operation and look for dirty floors,...

Overview:This session will make you a better Excel user, saving you time and costs, also provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Areas Covered in the Session:Learn how to use Excel's built in 21 CFR Part 11 featuresApply features required for GxP environments without programming macrosValidate your application with...

Overview:The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain, wider position as the EU CPR is representing the latest, most modern regulatory framework which is influencing other global legislators. Areas Covered in the Session:Basis principles and provisionsExperiences and obstacles from the implementation phaseOptions for compliance approaches and available supporting toolsRemaining issues and future perspectives and ac...

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Why should you Attend: Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provid...

How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides proper documentation. Why You Should Attend: Your failure to understand and properly respond to a 483 issued to you at the conclusion of an FDA inspection may q...

Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Why Should you attend: Today's headlines are filled with instances of cyber attacks resulting in denial of service, data theft or compromise and even ransomware holding critica...

The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer. Why should you Attend: This presentation gives you the essential information you need to write a successful plan. Many companies try to implement Risk Management usin...

This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Why should you Attend: FDA and ISO call for change control but do not provide any further guidance as to how to create a compliant system. The situ...

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Why should you Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qual...