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| Articles by John Robinson |
191. Biological Facility Design for Compliance - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: The field of biological facility design has been one of the most evolving engineering practices over the last 30 years. In the 1980s most biological facilities were modeled after generations of antibiotic production. These were large and suffered with significant bioburden problems. By the...
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192. The FDA Drug Development Process - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: This web presentation will provide the attendee a comprehensive overview of the FDA Drug Development Process, IND/NDA applications and GCP, GLP and GMP regulations.
Attendees will receive a foundation of knowledge about FDA's Drug Development Process, IND/NDA submission preparatio...
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193. Responding to FDA 483's - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording.
This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put ...
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194. Effective Training Practices for FDA Compliance - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how to design an effective training program, who is responsible for training, training effectiveness and training docum...
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195. Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities - Webi
November 24, 2013
Overview: This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Over time, there have been several misunderstandings between supplier / contractors and pharmaceuti...
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196. Biosimilars in the US, Europe and Canada - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: The approach to biosimilars in the US, Europe and Canada has differed significantly. Trying to develop and market a biosimilar involves careful consideration. Among the issues to consider carefully are the Reference Product, requirements for chemical/biological comparison of the Reference ...
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197. Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs) -
November 24, 2013
Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
It will begin with a strategic view of SOPs in a company and how SOPs can hel...
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198. South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar by GlobalCompliance
November 24, 2013
Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in ...
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199. Premarket Approval (PMA) Agreement with FDA for the Medical Device Companies - Webinar by GlobalCom
November 24, 2013
Overview: The Premarket Approval (PMA) pathway is complex. The PMA application needs to provide a reasonable assurance that the device is safe and effective for its intended use (21 USC 360e(d)(1)(A)). To do this, companies must submit valid scientific evidence (21 CFR 860.7(c)), typically derived f...
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200. U.S. FDA's Strategic Priorities - 2014 and Beyond - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2014. Such a review will focus on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing qualit...
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GENE MYERS
Author of four books and two screenplays; frequent magazine contributor. I have four other books "in...more
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TIM FAY
After 60-plus years of living, I am just trying to pass down some of the information that I have lea...more
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LAURA JEEVES
At LeadGenerators, we specialise in content-led Online Marketing Strategies for our clients in the t...more
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ALEX BELSEY
I am the editor of QUAY Magazine, a B2B publication based in the South West of the UK. I am also the...more
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SUSAN FRIESEN
Located in the lower mainland of B.C., Susan Friesen is a visionary brand strategist, entrepreneur, ...more
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STEPHEN BYE
Steve Bye is currently a fiction writer, who published his first novel, ‘Looking Forward Through the...more
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SHALINI MITTAL
A postgraduate in Fashion Technology. Shalini is a writer at heart! Writing for her is an expression...more
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ADRIAN JOELE
I have been involved in nutrition and weight management for over 12 years and I like to share my kn...more
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JAMES KENNY
James is a Research Enthusiast that focuses on the understanding of how things work and can be impro...more
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Author: John Robinson
