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Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans This course provides the attendees with the tools needed to understand and implement acceptance sampling.
Instructors:
We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan’s performance using the operating characteristic (OC) curve.
Dan OLeary President, Ombu Enterprises
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. ..more
Statistical Concepts of Process Validation The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output"
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability.
The FDA Inspection Process: From SOP to 483
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management. ..more
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Good Documentation Practices for GMP Operations Whether you work in production or in a laboratory or if you conduct
investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices.
21 CFR Part 11 - Compliance for Electronic Records and Signatures This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.
Excel Spreadsheets and FDA Device Regulations
Kerry Paul Potter President, Summit Consulting, Inc. Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory. ..more
David Nettleton FDA Compliance Specialist,
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation Ten easy Steps". ..more
This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create
Jose Mora Principal Consultant, Atzari Consulting, LLC
electronic records.
Design Inputs - Design Outputs Traceability Matrix Principles of Lean Documents and Lean Configuration Design 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 information across various documents - a major source of errors.
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José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 29 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. ..more
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About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe