Jan
2015
Version 4 just released

With strategies and tools for fast, cost-effective Laboratory
Accreditation
With Quality Manual and SOPs for easy implementation
71 New Usersclub Additions
last update
December 1, 2014
- 20 SOPs
- 23 Examples/Checklists
- 7 Forms/Templates
- 4 Master Plans
- 4 Reference papers
- 13 Warning Letters

Online Audio Seminars come with 10+ Best Practice guides for easy implementation
Risk Based Validation of Computer Systems and Part 11 Compliance
With Strategies for FDA/EU Compliance and Tool Kits for effective implementation
Recorded, available at any time
Validation and Use of Cloud Computing in FDA&EU Regulated Environments
Comply with GXPs, Part 11, EU/PICS Annex 11 and other regulations
Recorded, available at any time
Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid
records
Recorded, available at any time
New OECD Guide: Using Computer Systems in GLP Studies
Understanding and Implementing the new OECD Guide for Computer Systems Recorded,
available at any time
FDA Compliant HPLC Qualification and Performance Testing
Learn how to select, conduct and document the right tests in the
right sequence
Recorded, available at any time
Managing Out of Trend Results in Pharmaceutical Quality Control
With Strategies and best Practice Guides for easy Implementation
Recorded, available at any time
Learning from Recent Warning Letters Related to Computer
Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions
Recorded, available with all reference material at any time
FDA/EU Compliant IT Infrastructure and Network Qualification
With Strategies and Tool Kit for Compliance and System Uptime
Recorded, available at any time
Validation and Use of Cloud Computing in FDA Regulated Environments
Comply with GXPs, Part 11, EU Annex 11 and other regulations
Recorded, available at any time
Laboratory Equipment Calibration and Qualification according to USP <1058>
With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time
Understanding the New EU-GMP Annex 15 on Validation and Qualification
New requirements and strategies for implementation
Recorded, available at any time
Understanding Quality by Design for the Pharmaceutical Industry
Introduction to Principles, Regulatory Activities and Industry Practices
Recorded, available at any time
Validation of Analytical Methods according to the New FDA Guidance
Understanding FDA's New Lifecycle Approach Towards Method Validation
Recorded, available at any time
Impact of Quality by Design on the Analytical Laboratory
Learn through examples on development and validation of analytical procedures
Recorded, available at any time
Understanding FDA's New Guide on
Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective implementation
Recorded, available on demand
Transfer of Analytical Methods According to the New USP
Chapter 1224
With SOPs, templates and examples for easy implementation
Recorded, available on demand
FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality
Control
With Strategies and best Practice Guides for easy Implementation
Recorded, available on demand
System Suitability Testing for FDA and USP Compliance
Setting parameters and limits for chromatographic and other methods
Recorded, available on demand
Analytical Equipment Qualification and System Validation for FDA Compliance
Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide
Recorded, available on demand
Managing Electronic Raw Data in Regulated Environments
Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU
compliance
Recorded, available on demand
FDA Compliant Use of (Certified) Reference Material
Strategies for selection, purchasing, testing and documentation
Recorded, available on demand
Regulatory Aspects of 'Biosimilar' Drugs
Understand and Implement recent FDA and updated EMA Guidances
Recorded, available at any time
Transfer of Analytical Procedures According to the New USP Chapter <1224>
With SOPs, templates and examples for easy implementation
Recorded, available at any time
Understanding and Implementing the New EU-PIC/S Annex 11
Prepare Yourself for the upcoming Inspections and Enforcement
Recorded, available at any time
Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy
Implementation
Recorded, available at any time
Qualification and Use of Virtual Networks in Regulated Environments
With Strategies and Tool Kit for Compliance and System Uptime
Recorded, available at any time
How to Prepare Yourself for FDA's on-going Part 11 Inspection
Program
Learn what the FDA is looking for and how to respond
Recorded
Learning
from Recent Warning Letters Related to GMP Laboratory Controls
For Preparation of FDA and International GMP Laboratory Inspections
Recorded, available at any time

with 10+ validation examples, seminar with FDA's Dennis Cantellops and
Ludwig Huber and with 13 SOPs for easy implementation.