Attendees did get free access to a Labcompliance website with lot's of
reference material. Examples included: Master plans checklists,
examples, SOPs, and USP presentations. The material will help to
easily implement what they have leaned during the workshop.

All seminars come with 10+ best practice documents, such
as SOPs, checklists, master plans
Ensuring Integrity and Security of Electronic Records for FDA Compliance
Comply with new FDA inspection practices and EU Annex 11 requirements
Recorded
Ensuring Integrity and Security of Laboratory Data
Comply with new FDA inspection practices and EU Annex 11 requirements
Recorded
Periodic Review and Evaluation of Computer Systems
With strategies and tools for FDA and EU compliance
Recorded
Understanding and Implementing the New Final EU Annex 11
Learn about specific requirements and get tools for implementation
Recorded
ecorded
Electronic Raw Data in Regulated Environments
Definition, generation and archiving for FDA Part 11, HIPAA and SOX
compliance
Recorded
FDA's 21 CFR Part 11
Introduction and Strategies and Tools for Implementation
Recorded
Cost Effective Electronic Data Archiving for FDA Compliance
Understanding and Implementing the New GAMP Guide
Recorded
Electronic Audit Trails for FDA Compliance
Requirements - Design - Implementation - Validation -
Documentation
Recorded
FDA
Compliant Electronic Records Management
Recorded
Using
the SAFE Standard for Digital Signatures
For legally enforceable IP Protection, Electronic Transactions and FDA
Submissions
Recorded
Auditing Computer Systems for Part 11 and Annex 11
Compliance
Prepare your organization for upcoming FDA and EU inspection
Recorded
Laboratories
Validation of
Computerized Laboratory Systems
Implementing the new GAMP Laboratory Systems
Guide
Recorded, available at any time
Validation of
Software and Computer Systems in Analytical Laboratories
Recorded, available at any time
IT Infrastructure and Network Qualification: Step-by-Step
With Strategies and Tool Kit for Compliance and System Uptime
October 6, 2011
Assessment of
Software and Computer System Suppliers
Recorded, available at any time
How to Avoid
the Top 10 Worst Computer Validation Mistakes
Recorded, available at any time
Validation of
Configurable Off-the Shelf Computer Systems (COTS)
Recorded, available at any time
FDA Compliant
Testing for Validation and Qualification
Recorded, available at any time
Computer
System Validation Master and Project Planning
Includes 10 SOPs and a master and project plan
Recorded, available at any time
Computer
System Validation
Requirements and strategies for implementation
Recorded, available at any time
Configuration
Management and Change Control of Computer Systems
Hardware - Firmware - Software - Networks
Recorded, available at any time
Computer
System Validation for GLP
How much is enough?
Recorded, available at any time
Retirement of
Computer Systems
Strategies for FDA Compliance and Tools for Implementation
Recorded, available at any time
FDA's New
Guidance on using Computers for Clinical Trials
Understanding FDA's New Approach Towards Computer Systems
Recorded, available at any time
Validation and
Use of MS Accessâ„¢ Databases in GxP and Part11 Environments
Recorded, available at any time
Validation and
Part11 Compliance of Chromatographic Data Systems
With 10 Validation Examples: From planning to system retirement
Recorded, available at any time
Validation and Part 11 Compliance of Electronic Document
Management Systems
With Validation Examples: From planning to system retirement
Recorded, available at any time
Contingency and Disaster Recovery Planning for Computer Systems (197)
To Ensure Business Continuity and Compliance
Recorded, available at any time
Cost Effective Software and Computer System Validation
Take Advantage of New Recommendations from
FDA, EU Annex 11 and GAMP® 5
Recorded, available at any time
Writing
Effective Test Scripts and Validation Protocols for the
Bio/Pharmaceutical Industry
Recorded, available at any time
Validation of Existing/Legacy Computer Systems
FDA/EU requirements and strategies and tools for implementation
Recorded, available at any time
Auditing Computer Systems in Manufacturing and Laboratories
For Validation and Part 11 Compliance in Pharmaceutical and Device
Industries
Recorded, available at any time
Master Planning for Software and Computer Validation
With examples for master and several project plans
Requirement Management for Equipment and Computer Systems
Strategies for Development, Documentation and Updates or Requirement
Specifications
Recorded, available at any time
Validation and Use of Excel® Spreadsheets in Regulated
Environments
With FDA's Dennis Cantellops as Guest Speaker
Comply with GxPs, Part11, HIPAA, SOX and other regulations.
Recorded, available at any time
Risk Based Validation of Software and Computer Systems
Strategies for FDA/EU Compliance and Tools for Implementation
Recorded, available at any time
Computer System Validation: Step-by-Step
With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
Recorded, available at any time
Simplify Validation and Qualification with ASTM E2500
Cost Effective Alternative for Equipment Qualification and System
Validation
Recorded, available at any time
Learning from Recent FDA Warning Letters Related to Computer
System Validation and Part 11
With Case Studies to Avoid and Respond to
483's and Warning Letters
Recorded, available at any time
How much Validation is Enough?
Developing a Company Wide Strategy and Tools for Cost-effective
Implementation
Recorded, available at any time
Validation of Excel® Spreadsheets for Regulated Environments:
Step-by-Step
With Case Studies and Validation Protocols for Easy Implementation
Recorded, available at any time
Understanding and Implementing the New Final EU Annex 11
Learn about specific requirements and get tools for implementation
Recorded, available at any time
Auditing Computer Systems for Part 11 and Annex 11 Compliance
Prepare your organization for upcoming FDA and EU inspection
Recorded, available at any time
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Comply with FDA Part 11, the PIC/s Good Practice Guide and the
EU Annex 11
Recorded, available at any time