VALQUAL INTL.
Module
Topics
Days
1
Methods Development, Validation Procedures &
Conformity Assessment in the Analytical Laboratory
2-3
2
Qualification and Validation of Lab Systems and
Validation in the Pharmaceutical Laboratory
(IQ/OQ/PQ) / Plant Equipment
2
3
Cleaning Validation and Compliance Issues for the
Pharma, Biotech and Medical Device Industries
2
4
Good Distribution Practices (GDP) & Directives:
EU/WHO/Pedigree Law
2
5
Process Analytical Technology (PAT) Highlights
2
6
The Qualified Person (QP) - Relevance, Role,
Responsibilities and Requirements in the Regulated
Industries/Quality Systems
2
7
Trends and Highlights of Global Compliance Issues -
Risk Management Approach (ICH, EMEA, WHO)
2
8
Study Director, QAU & Management: Roles and
Responsibilities in the GLPs (FDA/OECD)
2
9
Highlights of FDA/OECD Good Laboratory Practices
3
10
Pharmaceutical Development, Process Optimization
and QA/QC Validation Issues
2
11
Integration of ICH Directives, Risk Management & the
GMP's / FDA's Science Based Policy
2
12
QA/QC & Validation Issues in the Water Analysis
Laboratory
2
13
FDA Enforcement Actions, Deviations & CAPA System
2
14
Development & Validation of Methods (USP, ICH)
1
DO YOU NEED A CUSTOMIZED TRAINING COURSE?
CONTACT US TODAY TO DISCUSS YOUR NEEDS!
Training Modules
Copyright © 2009 ValQual Intl. All rights reserved.  
Top | Home | Contact Us   
For more information contact:

Dr. Shib Mookherjea
ValQual International
P.O. Box 6930
Santa Barbara, CA 93160

Phone: 201-615-6346
Fax: 805-964-0374

shib@valqualintl.com


Administrative Manager
Shamarie Pierce
Fax: 303-974-5982

spierce@valqualintl.com