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| Articles by John Robinson |
161. 2-day In-person Seminar on Verification vs. Validation - Product Process Software and QMS at Las Ve
January 28, 2014
Overview:
This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test ca...
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162. 2-day In-person seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules at
January 28, 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 an...
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163. 2-day In-person seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules at
January 28, 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 an...
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164. 2-day In-person Seminar on Writing and Managing SOPs Effectively for GMP Operations at Los Angeles,
January 28, 2014
Overview:
This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed a...
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165. 2-day In-person Seminar on Acceptance Sampling - Methods and Applications at Boston, MA
January 28, 2014
Overview:
Many companies use acceptance sampling as a standard business practice. The most common applications use attribute sampling based on ANSI/ASQ Z1.4 andZero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common methods are not always the best approaches. This seminar...
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166. 2-day In-person Seminar on Statistics for the Non-Statistician at Sao Paulo, Brazil
January 28, 2014
Overview:
Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultim...
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167. 2-day In-person Seminar on Statistics for the Non-Statistician at Zürich, Switzerland
January 28, 2014
Overview:
Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultim...
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168. 2-day In-person seminar on Effective Complaint Handling, Medical Device Reporting and Recalls at Ph
January 08, 2014
Overview:
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Th...
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169. 2-day In-person seminar on Implementing Risk Management Principles and Activities within a Quality
January 08, 2014
Overview:
Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycl...
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170. 2-day In-person seminar on Implementing Risk Management Principles and Activities within a Quality
January 08, 2014
Overview:
Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycl...
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Author: John Robinson
