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Author Spotlight
CACEY TAYLOR

Im just a man who likes to be happy and see others happy. Im into home business, sports, family, and...more
AYESHA GULZAR

Medical and Pharmaceutical Research writer Doctor of Pharmacy/Pharm D /RPh ...more
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The Word of God is as, “Sweet as Honey”. God has Taken Me Through a Whole Lot of Things...more
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Author: John Robinson
Displaying 91 to 100 of 270 articles < Back | Next >
Pages: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27
 Articles by John Robinson 
91. 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Config
May 29, 2014

Overview: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional ...

92. FDA Device Software Regulation
May 29, 2014

Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify trea...

93. Best Practices in Supplier Management
May 29, 2014

Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards.

Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers an...

94. How to Conduct a Hazard Analysis/Risk Assessment
May 29, 2014

Overview: This interactive webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance.

What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validat...

95. Update on FDA 510(k) Review Process, Hurdles and Good Practices on 510(k) Preparation and Clearance
May 29, 2014

Overview: This webinar is intended to share 510(k) hurdles and good practices, in particular, how to prepare a 510(k) in a sufficiently adequate manner with increased quality to expedite review process. The premarket notification [510(k)] is the most common pathway to market for medical devices inc...

96. ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation
May 29, 2014

Overview: Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.

ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their primary language. This webinar i...

97. GxP Computer System Validation, The investigator's Point of View
May 29, 2014

Overview: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies ...

98. Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
May 29, 2014

Overview: HACCP elements of the Codex Alimentarius required by GFSI auditing schemes. The process by which the HACCP program is tested.

HACCP validation and verification is an often neglected area of the HACCP program. GFSI audits focus on HACCP will result in an increased scrutiny of the f...

99. HACCP Validation and Verification
May 29, 2014

Overview: HACCP elements of the Codex Alimentarius required by GFSI auditing schemes. The process by which the HACCP program is tested.

HACCP validation and verification is an often neglected area of the HACCP program. GFSI audits focus on HACCP will result in an increased scrutiny of the f...

100. Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
May 29, 2014

Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not ...

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Author of four books and two screenplays; frequent magazine contributor. I have four other books "in...more

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