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| Articles by John Robinson |
101. Understanding and Preparing for FDA's on-going Part 11 Inspection Program
May 29, 2014
Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 12 months FDA issued more than 10 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic rec...
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102. Meet FDA Expectations for a Tougher Supplier Audit Program
May 29, 2014
Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception.
Industry must be prepared to adapt, and recognize that such adaptation will act...
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103. 2-day In-person Seminar on Global Medical Device Regulation at Denver, CO
May 20, 2014
Overview: This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements,...
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104. 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems a
May 20, 2014
The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the req...
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105. seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules
May 20, 2014
Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and detai...
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106. 2-day In-person Seminar on Applied Statistics for QA, QC, Manufacturing, and Design Control at San
April 30, 2014
Overview:
The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: • How to calculate confidence interva...
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107. 2-day In-person seminar on Combination Products: How to Get Your Combination Product Approved and o
April 30, 2014
Overview:
This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulat...
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108. 2-day In-person Seminar on Understanding FDA and Avoiding Inspections Leading to Warning Letters, S
April 30, 2014
Overview:
FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or reca...
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109. 2-day In-person Seminar on The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating
April 30, 2014
Overview:
This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, and efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discuss...
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110. 2-day In-person seminar on Medical Device Software Risk Management and Assurance Case at Boston, MA
April 30, 2014
Overview:
Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct imple...
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Author: John Robinson
