Sept
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
April 20, 2016
- 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
Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and
hybrid records
February 4, 2016
Learning from Recent Warning Letters related to Part 11 and Computer Validation
With Clear Recommendations for Corrective and Preventive Actions
Recorded, available at any time
Understanding the Final FDA Guidance for Validation of Analytical Methods
With 10+ best practice guides for easy implementation
Recorded, available at any time
Analytical Instrument Qualification According the new
Revision of
USP <1058>
With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time
Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
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
Quality by Design (QbD) for Development and Validation of Analytical Methods
Learn how to design robust analytical for easy transfer and to avoid OOS
situations
Recorded
FDA/EU Compliant Handling of OOX Test Results
Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS
results
Recorded
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
Understanding Quality by Design for the Pharmaceutical Industry
Introduction to Principles, Regulatory Activities and Industry Practices
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
Managing Electronic Raw Data in Regulated Environments
Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU
compliance
Recorded, available on demand
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.