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| Articles by John Robinson |
181. Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
The presentation explores the statistical underpinnings of these two phrases. T...
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182. cGMP: Strategies for Implementation and Compliance for Phase I Investigational Drug and Biologic Pr
December 04, 2013
Overview: Because certain requirements in 21 CFR part 211, which implement § 501(a)(2)(B) of the FD&C Act, were directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production (e.g., those regulations that address validation of manufacturi...
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183. The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and
December 04, 2013
Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar cov...
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184. "Zero Defects" and the cGMPs - Pros and Cons - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).
They are then required to translate those regulations into procedures and work instructi...
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185. Elements of the Lot Disposition Process - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components.
It will describ...
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186. Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations fo
December 04, 2013
Overview: What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will revie...
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187. Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 com...
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188. South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar by GlobalCompliance
December 04, 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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189. Medical Device Classification - US and the EU as per MDD, CMDR and GHTF - Webinar by GlobalComplian
December 04, 2013
Overview: The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach i...
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190. European Union Filings and Registrations - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specif...
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Author: John Robinson
