Training and Teaching
Listings
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Label Promotion of Drugs and Medical Devices 2018
Training and Teaching Fremont (California) April 19, 2018 FreeOverview: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why should you Attend: This session will discuss commen...
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Where Does your Organization Stand?
Training and Teaching Fremont (California) April 19, 2018 FreeOverview: We will discuss the pro's and con's of a implementing a zero incident workplace culture and describe how to determine if you are doing it right. Why should you Attend: A zero injury workplace safety cultures consist of shared beliefs, pract...
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Why Organizations need to use CAPA, What is its Purpose?
Training and Teaching Fremont (California) April 19, 2018 FreeOverview: In this webinar, we will review CAPA as part of Quality Management System (QMS), reasons why organizations need to use CAPA, what is its purpose. We will describe CAPA concepts and procedures. We will also describe FDA investigation procedu...
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How to Conduct Effective Close out Meetings
Training and Teaching Fremont (California) April 19, 2018 FreeOverview: This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your ex...
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FDA Policy and Goals Regarding the 483 Response - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: 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 Lette...
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What Sponsors Expect and How to Meet their Expectations
Training and Teaching Fremont (California) April 19, 2018 FreeOverview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place fo...
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SOP Development - How to Write Them Effectively For Compliance - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: 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...
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Steam Sterilization Microbiology and Autoclave Performance - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: 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 perform...
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Software Validation Program That will Satisfy FDA Requirements - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: 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 FD...
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Challenges to relevant Financial Statements - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: This course will cover both the telecommunication and technology industries and pinpoint how company operations can be improved. Why should you Attend: With my LIFA certification and 15 years in international finance topics such as IFRS, GA...
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EU Clinical Trial regulation - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: 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...
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Audit - How to Improve Your Internal Audit program - 2017
Training and Teaching Fremont (California) April 20, 2017 FreeOverview: This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. Why should you Attend: Continuous Improvemen...
