An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information...

In this webinar, I will discuss the importance of being ready for a Notice of Inspection (NOI) - also referred to as audit by Immigration and Customs Enforcement (ICE), what happens when an ICE audit occurs, and an employer’s potential liability for I-9 errors discovered by ICE in the audit. The webinar will discuss the need for preventive maintenance – an employer performing an internal I-9 audit - which should discover many of th...

This complaint management webinar will include the requirements for defining, documenting, and implementing a customer complaint handling system, including the customer complaints procedure for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This webinar will discuss the best way to document customer feedback management, what constitutes a customer service complaint, and what do with "non-compl...

To magnify the knowledge in the field of Microbiology and Biotechnology Set to take place on 21st and 23rd June 2017, the 4th annual event in the sell-out Pharmaceutical Microbiology series will bring together all levels of industry professionals, providing essential insights into the latest advancements in practice and technology, developments in regulation and the global harmonisation of evolving microbiology methods. Join us as we ask quest...

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...

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...

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. Why should you Attend: Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation orcontinuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met. Areas Cov...