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
|
