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Jim Turner is a USA based author of Legal issues related to estate planning, will & trust , busyness...more
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In regards to earning money online, everybody wishes to, and everybody strives to, but not many end ...more
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Author: John Robinson
Displaying 121 to 130 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 
121. Calibration and Qualification in Analytical Laboratories
April 24, 2014

Overview:

Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. D...

122. Batch Production Record, Device History Record Review and Quality Assessment
April 24, 2014

Overview:

Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished ...

123. Common Sense Water System Validation
April 24, 2014

Overview:

Water system validation is often considered a necessary evil intended to merely satisfy a regulatory expectation. If done using a one-size-fits-all template, it probably satisfies regulatory requirements but is indeed a waste of time when it could be a valuable "insurance policy". ...

124. Safety Critical Software - Software Risk Management
April 24, 2014

Overview: Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained.

Questions like:

How much detail is required in the requirement specification?

What is a software unit? ...

125. Purchasing and Supplier Controls in the Medical Device Industry
April 24, 2014

Overview:

This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.

Supplier qualification and assessment is required in both the QSR regulations and I...

126. Emerging Issues in Food Safety
April 14, 2014

Overview:

This webinar will address the complexity of defining safe food and examine the factors that impact on microbiological food safety. We will look at the changing nature of foodborne/food transmitted pathogens and the influence of demographics and geography on the changing landscape. ...

127. Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements
April 14, 2014

Overview:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.

One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard anal...

128. Master Drug and Medical Device Reporting (MDRs)
April 14, 2014

Overview:

Manufacturers of APIs, Final Drug Products and Medical Devices are required to report to the FDA when they learn that any of their products may have caused or contributed to a death or serious injury or if there is an anticipated patient risk. Manufacturers must report to the FDA w...

129. Best Practices in Complaint Management
April 14, 2014

Overview:

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about m...

130. True Safety vs. Regulatory Compliance
April 14, 2014

Overview:

Safety professionals, managers, operations executives, and Senior Leaders are under moral, legal, and financial obligations to establish workplaces that are safe and run efficiently. At a very practical level, however, a disconnect between regulatory (legal requirements) and safety...

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