Tag Archives: Globalcompliancepanel

Validating Excel And Word Applications Documents – Webinar By Globalcompliancepanel

Posted on January 27, 2012 by

Overview: Both the U.S. FDA and the EU’s MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e.g., MS-Excel and MS-Word, or similar. How can these be … Continue reading →

Posted in Home Business | Tagged Allocation Of Scarce Resources, Applications, Applications Software, Common Software, Company Areas, Company Quality, Cots Software, Documents, Excel, Existing System, Globalcompliancepanel, Guidance Documents, Ich Q9, Iso 14971, Office Applications, Realistic Limits, Regulatory Compliance, Risk Allocation, Risk Management Systems, Software Apps, Validating, Validation Problems, Verification And Validation, Warning Letters, Webinar, Word, Word Applications | Leave a comment

Medical Device Changes And The 510(k) – Webinar By Globalcompliancepanel

Posted on February 25, 2011 by

Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need … Continue reading →

Posted in Home Business | Tagged 510k, Anticipation, Changes, Current, Device, Efficacy, Fda, Globalcompliancepanel, Group Findings, Implementation, Matrix Format, Meaningful Results, Medical, Medical Device, Medical Industry, Minor Changes, Product Safety, Profile Field, Rationale, Risk Management Tools, Rocket Science, Submission, Urgency, Webinar, Working Group | Leave a comment

Validating Rapid Microbiological Methods – Webinar By Globalcompliancepanel

Posted on October 23, 2010 by

Overview: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine … Continue reading →

Posted in Home Business | Tagged Acceptance Criteria, Analytical Methods, Control Strategies, Design Qualification, Functional Design, Globalcompliancepanel, Instrumentation Software, Iq Oq, Method Validation, Methods, Microbial Control, Microbiological, Microbiological Methods, Novel Technology, Performance Qualifications, Pharmacopoeia, Quality C, Rapid, Requirements Traceability Matrix, Supplier Assessment, Technology Platforms, Validating, Validation Master Plan, Validation Program, Validation Strategy, Webinar | Leave a comment

Webinar On Pharmacovigilance Audit – Webinar By Globalcompliancepanel

Posted on March 30, 2010 by

Overview: This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company’s pharmacovigilance operations to applicable best practices. … Continue reading →

Posted in Home Business | Tagged 9a, Adverse Events, Amendment Act, Attendees, Audit, Background Matrix, Cioms, Clinical Trials Directive, Collection Assessment, Drug Safety, Drug Withdrawals, E2c, E2e, Globalcompliancepanel, International Organizations, Medical Sciences, Pharmac, Pharmacovigilance, Regulatory Background, Regulatory Bodies, Risk Management, Safety Concerns, Safety Regulations, Webinar | Leave a comment

The Most Common Problems in FDA Software Validation & Verification – Webinar By GlobalCompliancePanel

Posted on January 17, 2010 by

Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S: “The Agency … Continue reading →

Posted in Home Business | Tagged Applicable Regulations, Common, Common Sense Approach, Electronic Records, Electronic Signatures, Enforcement Actions, Fda Compliance, Fda Inspection, Firm Marketing, Globalcompliancepanel, Industry Compliance, Inspectional Observations, Marketing Products, Most, Old Hands, Pharmaceutical Medical Device, Problems, Quality Systems, Safety And Reliability, Software, Software Validation, Software Verification, Validation, Validation Issues, Verification, Verification And Validation, Warning Letters, Webinar | Leave a comment