We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization. Why should you Attend: Because as much as we try, most regulated industries don't have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competenc...

Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program. Areas Covered In the Session: Discuss what FDA is...

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...

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...

FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. Why you should attend: Learn how to respond to FDA 483's and the best way to write the response. Learn the new policy from FDA regarding how and when to respond. Learn the best way to respond in...

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Why should you Attend: A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profil...

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Areas Covered in the Session: Four approaches for analytical method transfer and testing Responsibilities of the transferring and receiving laboratory Develop...

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufac...