Address: Al Hawiy St., Hitteen Dist., Riyadh , Saudi Arabia
P.O.Box: 13516
Phone: +966920019011
Mobile: +966532375500
Consultation Email: info@mesned.com
Training Email: training@mesned.com
CRO Email: cro@mesned.com
Pharmacovigilance Email: bd@mesned.com
Who should attend?
R&D, QC and RA department
personnel
Technical staff involving in
method development and validation
Quality
departments supervisors
Topics Covered:
Impurities in drug substance
1.1 Origen and classification of
impurities in drug substance
1.2 Potential impurity profile
1.3 Characterization of
impurities
1.4 Guidelines for impurities
control
Impurities and degradation
products in drug products
2.1 Degradation impurities
2.2 Drug-excipient degradation
products
2.3 Qualification of impurities
and degradation
Setting and Justification of
impurities and degradation specifications
3.1 ICH Q3A and Q3B thresholds
3.2 ICH Q6 guideline for
specification
3.3 Case studies for
specifications settings
Genotoxic impurities
4.1 ICH M7 classification of
impurities
4.2 QSAR and Ames test
4.3 Setting specifications for
genotoxic impurities
Forced Degradation and mass
balance
5.1 Degradation patterns for
drug substances
5.2 Design and reporting forced
degradation study
5.3 Mass imbalance
troubleshooting
Residual solvents
6.1 Classification of solvents
as per ICH Q3
6.2 Setting specifications for
residual solvents
Analytical Methods for
impurities and degradation
7.1 Development of stability
indicating methods
7.2 Validation of analytical
methods
MPCC (a member of
Bana Group) was established in 2005 and is now the healthcare industry’s FIRST
choice for sustainable outsourcing of Regulatory affairs, Clinical Research and
Technical consulting services in the Middle East.