50 New Usersclub Additions
- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

Online Audio Seminars come with 10+ Best Practice guides for easy implementation
How to Effectively Build a GLP Laboratory
Step-by-step from design to compliant and cost-effective implementation
Recorded, available at any time
Setting up a Quality System for Pharmaceutical Laboratories
Understanding and Implementing ICH Q10 and other Quality Systems
Recorded, available at any time
Transfer of Analytical Procedures According to the New USP Chapter <1224>
With SOPs, templates and examples for easy implementation
March 21, 2013
Quality by Design (QbD) for Analytical Method Development and
Validation
Learn how to design robustness for easy transfer and to avoid
OOS situations
Recorded, available at any time
Efficient Training Practices for FDA and International Compliance
Learn what to train - How much to Train - How to Document
Effectiveness
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 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
Verification of
Compendial Methods according to the Revised USP Chapter <1226>
Understand the new risk based approach and get real world case
studies for testing
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
Validation and Use of Excel® Spreadsheets in Regulated Environments
Comply with Part 11, QSR, and Annex 11.
Recorded
Available at any time
Implementing
the New USP Chapters 232/233 for Elemental Impurities
Learn how to comply with FDA, USP and ICH Requirements
Recorded, available at any time
Verification of Compendial Methods according to the Revised USP
Chapter <1226>
Understand the new risk based approach and get real world case
studies for testing
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
Validation of Bioanalytical Methods and Procedures
Conduct and Document for Efficiency and FDA&EMA Compliance
Recorded, available at any time
Raw Data
in FDA Regulated Environments
FDA/EU compliant recording, maintenance and archiving
Recorded, available at any time
Learning
from Recent Warning Letters Related to GMP Laboratory Controls
For Preparation of FDA and International GMP Laboratory Inspections
Recorded, available at any time
Development and Validation of Stability Indicating Methods for
FDA/ICH
Compliance
Sample generation - method development - validation - documentation
Recorded, available at any time
FDA
Compliant Use of (Certified) Reference Material
With 10+ Best Practices for easy Implementation
Recorded, available at any time
Analytical Instrument Qualification According to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
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.