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 The
most frequently cited cGMP non-compliances are often found in analytical
laboratories - showing the importance of the pharmaceutical quality
control and the Quality Control Manager. Further, the QC Manager has to
observe a multitude of GMP requirements (FDA, EMA, WHO, Pharmacopoeias,
etc.).
The programme ECA Certified Quality Control Manager lets you qualify as
a specialist for analytical GMP laboratories. It provides guidance on
ways of attaining best regulatory practice and compliance. In addition,
it addresses tools for the efficient and effective management and
performance of quality control laboratories today.
This programme will be of significant value to employees both in routine
quality control and in analytical development laboratories, who are
responsible for GMP compliance and laboratory organisations:
- Analytical scientists
- Analytical laboratory managers / supervisors
- Employees working in the incoming goods control of APIs, excipients,
and packaging materials
- Contract laboratories personnel
- Auditors responsible for assessing laboratory compliance and
performance
For questions relative to the ECA Certified Quality Control Manager,
please contact
heimes@gmp-compliance.org.
To receive the certificate, the applicant must attend three out of the
following courses / conferences. After attending the third course, the
applicant obtains the certificate "ECA Certified Quality Control
Manager".
- Integrating Analytical Equipment Qualification and Computerised System
Validation
- Maximising HPLC Productivity
- Quality of Pharmaceutical Packaging Systems
- Quality Control of Raw Materials
- Measurement Uncertainty
- Validation of Analytical Test Procedures
- Out-of-Specification Results
- Ensuring Analytical Control Laboratory Compliance with FDA & USP
Requirements
- Impurities
- Dissolution Testing
- Efficient and Effective Quality Management in the Analytical Laboratory
- Analytical Data - Interpretation and Treatment
- FDA Compliance in Analytical Laboratories
- Reference Standards
- Elastomeric Closures for Injections
- Lab Equipment Qualification
- Plastic Packaging Materials
- Printed Packaging Materials
- Setting Specifications
- Stability Testing
- The Pharmaceutical Laboratory Manager
To get to the calendar with all courses and conferences currently offered
for this programme - including a link to the contents and a booking form
- please go here.
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