Personnel training or, in other words, suitable and updated technical qualification to perform in a GxP environment is a requirement.
The new ICH Q8 Q9 and Q10 guides are based on the knowledge of tools and techniques not familiar to most of the technical personnel in the pharmaceutical sector:
Some of the tools are:
• Process mapping.
• Risk Analysis.
• Design of experiments.
• Multivariate statistics and other chemometric tools.
• Quality management techniques: ISO, Lean Manufacturing, Six-Sigma etc.
With the objective of extending the knowledge of these new tools, at least at a basic level, and to insist on the classical ones, we have elaborated courses based on our clients’ demands. |
TITLE |
CODE |
GMP/ICH Actualization. GMP in the 21st century.
Impact on the API, parenterals and biologic drugs manufacturing |
GMP-ICH |
Production of Pharmaceutical active ingredients. Part II cGMP’s, ICH Q7A
QbD application to the development and manufacturing of API’s. ICH Q11 |
GMP 1 |
Production of sterile drugs. Actualization of Annex 1 of the cGMP’s.
Application of Risk Analysis |
GMP 2 |
Production of biological drugs. Actualization of Annex 2of the cGMP’s.
Application of Risk Analysis |
GMP 3 |
| Process validation. The new QbD vision of the FDA “Process
Validation” Guidance |
GMP 4 |
Computer system validation and qualification of the infrastructures.
The new vision based on risks of GAMP 5. Annex 11 cGMP’s. |
GMP 5 |
QbD Training. Tools to guarantee Total Quality:
ICH Q8, Q9 & Q10. Lean-Six Sigma |
QbD |
The new ICH Q8/Q9/Q10 regulatory environment.
How to start the road to quality by design?
Advantages and ROI. ICH Q8 |
QbD 1 |
Quality by Design, Design Space and PAT
ICH Q8 Pharmaceutical Development |
QbD 2 |
Risk Management according to ICH Q9 (Part III GMP)
Practical applications |
QbD 3 |
Pharmaceutical Quality System ICH Q10
Lean-Six Sigma applications |
QbD 4 |
Statistical tools and design of experiments.
DOE for pharmaceutical industry. |
QbD 5 |
Good Clinical Practices (GCP) Training
Good Laboratory Practices (GLP) Training |
GLP-GCP |
Good laboratory practices (BPL/GLP):
Philosophies, News and Trends. |
GLP 1 |
Approaching the GLP from the Inspection process:
Preparing and Living the inspection |
GLP 2 |
Beyond GCP:
Process analysis and Quantitative Quality Indicators in Clinical Investigation. |
GCP 1 |
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