This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. Why should you Attend: This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. Areas Covered in the Session: Manufacturing pr...

Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. Why should you Attend: This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also...

FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Why should you Attend: The new import entry filing requirements became effective in 2016 and are posing problems for user. Failure to provide the correct information creates costly delays and, in some cases, the fru...

This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Areas Covered in the Session: Elements of a cross-procedural CAPA program Applications of CAPA CAPA Data, and best practices for its use Application of risk management to CAPA program Who Will Benefit: QA management CAPA coordinator Regulatory Affairs management Executive management Consultants Quality System Auditors

This program covers a general overview of accounting and financial information and how to interpret reports so that you can make the best decisions in your role as a manager in your organization. Why should you Attend: No matter the title you hold or how brilliant your idea is, it usually comes down to one thing the bottom line dollars and cents. Whether you're currently in apposition of organizational responsibility, or desire to advance your...

Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. Why should you Attend: Learn to develop a large new revenue stream while protecting your senior patients from unnecessary surgeries, improve their quality of life and help lower healthcare costs. With as little as 1 patient per day you could develop $10,000+ revenues per month. Areas Covered...

This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. Why should you Attend: Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Areas Covered in the Session: How t...

Transition between Directive 2001/20/EC and Regulation EU No 536/2014 Until the Clinical Trials Regulation EU No will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC. Why should you Attend: Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States Areas Cove...

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries. Areas Covered in the Session: Software validation more than testing Requirements tracea...

This course will cover both the telecommunication and technology industries and pinpoint how company operations can be improved. Why should you Attend: With my LIFA certification and 15 years in international finance topics such as IFRS, GAAP, and international accounting in the semiconductor, transportation, and consumer products distribution, I can provide insight into the construction of financial statements. Areas Covered in the Session: D...