davidross759
| Name | Country | Gender |
| - | - | Male |
| Biography | Occupation | Homepage |
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Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
by: davidross759, 2 pagesDesign Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate ...
Clinical Trial Auditing - Identifying Risks and Building a More Compliant and Successful Trial
by: davidross759, 1 pagesThis presentation will help with preparing the site and the study team with how to comply with the new 21 CFR part 11 regulations, how to identify risk of noncompliance, and how to insure compliance.
Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment
by: davidross759, 2 pagesA summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed. A general review of environmental niches where they may be present will be ...
Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
by: davidross759, 2 pagesIntroduction and Regulatory Background ¡ There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. ¡ Current trends with the 510(k) process.
Avoiding Major Industry cGMP Failures – Recent Updates
by: davidross759, 2 pagesU. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (cGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They ...
The DHF, DMR, DHR, and the Technical File / Design Dossier - Regulatory Requirements
by: davidross759, 2 pagesThis webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR
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
by: davidross759, 2 pagesThis 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
Intelligent Routing for Temperature Sensitive Goods
by: davidross759, 2 pagesThe session will cover strategies to provide real-time cold chain temperature tracking and traceability. The goal is to help the supply chain identify opportunities for continuous improvement and to ...
Hazard Analysis – A practical guide
by: davidross759, 1 pagesIf you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an ...
Efficient Computer System Validation - 10 Easy Steps
by: davidross759, 1 pagesThis webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation ...
