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...

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...

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...

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. Why should you Attend: One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prep...

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...