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Training and System Implementation
Training
Bioanalytical
method validation and Sample analysis
At the completion of this training an individual will have a complete understanding of the new FDA requirements for bioanalytical method validation and sample analysis. This will include full coverage of the issues left unresolved by the FDA Guidelines and how best to resolve them.
Rational
outsourcing of Pharmaceutical testing
During the course of this training an individual will be exposed to all of the aspects of pharmaceutical outsourcing. This will include instruction on how to write an RFP, weight-select candidate laboratories, and evaluate the strengths/weaknesses of candidate laboratories. Also covered are aspects of setting up service agreements, activity management, communication, and complaint resolution.
The
ABCs of Service provider qualification
At the completion of this training an individual will have a complete understanding of the process involved in qualifying a contract service provider to perform cGMP or GLP compliant activities. This includes systems audit, vendor checklists, and the implementation of any required SOPs to provide the basis of qualification.
System implementation
Bioanalysis
Bioanalytical testing is pivotal to the support of clinical and non-clinical programs. SOPs will be established on behalf of the sponsor so that bioanalytical testing can be performed in a compliant manner whether this work is performed on- or off-site.
Stability
A stability program is the center of all CMC activities. SOPs will be established on behalf of the sponsor so that stability testing can be performed in a compliant manner whether this work is performed on- or off-site.
Raw
materials
A raw material testing program must be established regardless of whether the materials are commonly used in pharmaceutical products or not. SOPs will be established on behalf of the sponsor so that raw material testing can be performed in a compliant manner whether this work is performed on- or off-site.
Reference
standards
Reference standards and materials are a primary requisite of any analytical testing activity. Preparation, qualification, and management of reference materials must be established. SOPs will be established on behalf of the sponsor so that reference standard preparation, qualification, and use can be performed in a compliant manner whether this work is performed on- or off-site.
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Service areas
Compliance
and Techical Auditing
Training
and System implementation
Trouble
Shooting and Data Validation
Why use Pharmaceutical Outsource Solutions?