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Author: John Robinson
Displaying 81 to 90 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 
81. The Most Common Problems with Software Validation Processes
July 01, 2014

Overview:

This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit ...

82. Measurement Uncertainty in Microbiology
July 01, 2014

Overview:

Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the accreditation requirement for MU, including, what data to collect and how to analyze it. Also a practical step by step approach to data ...

83. Understanding Combination Products, Requests for Designation and Product Jurisdiction
July 01, 2014

Overview:

This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applicat...

84. Excel Spreadsheet Validation for FDA 21 CFR Part 11
July 01, 2014

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 CF...

85. ICH GCPs and the Clinical Research Process (Including Phase 0,1,2,3 and Phase 4 trials)
July 01, 2014

Overview:

This webinar provides all the necessary information concerning the ICH GCP-the only global GCP. ICH GCP is not only the only global GCP it is also the most current GCP. If you are involved with clinical trials the ICH GCP is a must for you.

This webinar presents a comprehe...

86. Customer Interactions: Law, Policies, Ethics
July 01, 2014

Overview:

The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or...

87. Key Concepts in Successful Water System Sanitization
July 01, 2014

Overview:

Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do wit...

88. Statistical Considerations for ICH Guidelines
June 16, 2014

This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines....

89. Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace
June 15, 2014

This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge ...

90. Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations fo
May 29, 2014

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 revi...

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