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...

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...

Over the next four to six years, healthcare organizations will find themselves in the midst of a shift in the way that healthcare is administered and monitored. According to research, patients will begin taking ownership of their healthcare which will create a deep ripple effect across IT networks that enable the day-to-day activities of the military. To address these seismic changes, the military is looking at how technology solutions will su...

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also cont...

This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product. Why should you Attend: This training provides FDA's current recommendations on this topic. Check out the specific areas covered below. If you are a sponsor of a clinical trial involving a drug, biologic, medical device or combination product, a clin...