2-Day Seminar with Workshops
Analytical Instrument Qualification and System Validation
With Dr. Ludwig Huber
14 & 15 June 2012, Ramada Plaza. Istanbul
For registration,
click here
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
Ensuring Integrity and Security of Electronic Records
for FDA Compliance
Comply with new FDA inspection practices and EU Annex 11
requirements
May 8, 2012
Configuration Management and Change Control for Networks
and Computer Systems
Changes of Hardware, Firmware, Software, Networks, Documentation
May 24, 2012
Validation and Use of Excel® Spreadsheets in Regulated Environments
Comply with Part 11, QSR, and Annex 11.
June 21, 2012
Selecting Acceptance Criteria for Regulatory Method Validation
Learn through case studies and get inspection ready documentation
July 10, 2012
Qualification and Use of Virtual Networks in Regulated Environments
With Strategies and Tool Kit for Compliance and System Uptime
July 12, 2012
Implementing
the New USP Chapters 232/233 for Elemental Impurities
Learn how to comply with FDA, USP and ICH Requirements
July 26, 2012
How to Survive FDA's 'New' Inspection and Enforcement Practices
With Industry Proven Tool Kits for Preparation, Conduct and
Follow-up
Recorded
Verification of Compendial Methods according to the New USP
Chapter <1226>
Understand the new risk based approach and get real world
case studies for testing
Recorded, available at any time
Implementing
the New USP Chapter <1224> for Analytical Method Transfer
With SOPs, templates and examples for effective implementation
Recorded, available at any time
Quality by Design (QbD) for Development and Validation of
Analytical Methods
Learn how to design robustness for easy transfer and to
avoid OOS situations
Recorded, available at any time
Qualification of Virtual Networks and Cloud Computing
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, available at any time
Analytical Instrument Qualification According to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded, available at any time
New release
with 46 SOPs
CD for training and tools for easy implementation
With master plans, 22 SOPs, Checklists, Examples, Audio seminar
Comply with FDA's Current Interpretation
Reference book for
Part 11 Implementation
For FDA/EU Compliance of Excel Spreadsheets
With seminar presentations, primer, SOPs, checklists and examples
www.fdawarningletter.com
250 GxP related FDA
EIR's/483's and Warning Letters