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| Articles by John Robinson |
61. Activities involved in Computer Systems Validation
June 06, 2016
Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing ...
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62. Rule relating to orphan drugs in Japan
May 24, 2016
Orphan drugs are those that are developed purely to treat rare diseases. The nature of orphan drugs is a little piquant: on the one hand, rare diseases affect very few people, but these cannot be ignored. On the other hand, orphan drugs, since they are so few in number, are not taken up usually by p...
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63. 02679D
October 22, 2015
NetZealous Announces Ongoing Seminar on The Topic, “The A to Z's of Troubleshooting of Pharmaceutical Water Systems” in Zurich, Switzerland. Dr. Teri C. Soli, President of Soli Pharma Solutions, Inc. will be the speaker at this seminar. This course is intended to equip participants an understanding ...
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64. Organizations that don't take HIPAA Privacy Security audits seriously could get into serious troubl
October 08, 2015
Business Associates and Covered Entities alike have been at the receiving end of HIPAA audit from the Office of Health and Human Services (HHS) inspectors for a while now. Why this sudden clamor for HIPAA compliance? It is because the federal government has now trained its guns on HIPAA compliance f...
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65. The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Wat
September 24, 2015
The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems Biofilm is critical to water systems. Water systems professionals need to have thorough microbiology-focused education about all aspects of water systems, such as proper design, validation,...
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66. Seminar on The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules
February 03, 2015
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 an...
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67. Seminar on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharma
February 03, 2015
Overview:
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understa...
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68. Applied Statistics for QA, QC, Manufacturing, and Design Control - 2-day In-person Workshop
February 03, 2015
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 in...
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69. Applied Statistics for Scientists and Engineers - 2-day In-person Seminar
February 03, 2015
Overview:
Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting sta...
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70. Clinical Drug Development and Approval Process - 2-day In-person Seminar
February 03, 2015
Overview:
Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will pro...
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Author: John Robinson
