This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product. Why should you Attend: This training provides FDA's current recommendations on this topic. Check out the specific areas covered below. If you are a sponsor of a clinical trial involving a drug, biologic, medical device or combination product, a clin...

You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards. Why should you Attend: This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is approp...

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...

This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. Why should you Attend: What is the result or impact of the regulatory environment on the business? Companies find themselves in the position of doing to...

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle. Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended ran...

This course begins with general principles of Project Management Business Administration (PMBA) and continues to elaborate on specific topics relevant to pre-bid scenarios, execution phase strategies, and close out dilemmas. Why should you Attend: Do you know how many successful projects it takes to cover the loss from one bad project? Do you understand the stress on a company when a project does not have positive cash flow? Do you want to be...

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Areas Covered in the Session: FDA and EU analytical instrument requirements Most common inspection problems Recommendations for firmware and software validation Roles an...

In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. Why should you Attend: Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your...

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Why should you Attend: We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation t...

This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC. Why Should you Attend: Form 1099-MISC is one of the most common Information Reporting Form that businesses, estates, trusts and non-profits are required to file at the end of the calendar year. It is also the Form 1099 that most commonly has errors identified by the IRS. Areas Covered in the Session: What name...