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...

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...

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...

Conference Series has been instrumental in conducting international Proteomics meetings for seven years, and very excited to expand Europe, America and Asia Pacific continents. Previous meetings were held in major cities like Valencia, Atlanta, Rome, with success the meetings again scheduled in three continents. 8th International Conference on Proteomics and Bioinformatics to be held during May 22-24, 2017 at Osaka, Japan. 9th Proteomics Meeti...

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...

DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. You should pay attention to the components of your advertising in mass media, such as volume; images; information prominence and conspicuousness; speed of the message subliminal messaging and "the take a...