This course will take you through the lifecycle of robust, accurate and precise relative potency assays, from inception, through regulatory compliant development, analysis, validation and performance monitoring.
Designed for business leaders with executive responsibilities, this course quickly identifies the areas of strategic impact, possible costs and the time lines associated with the new EU In Vitro Diagnostics Regulations.
The current regulatory focus on data integrity means that all personnel engaged in pharmaceutical manufacturing and testing need to be aware of regulators’ expectations. Data integrity breaches can occur accidentally
This Seminar will provide information key to managing a successful partnership with Vendors who provide essential services in ensuring that patient safety and data integrity are of an acceptable quality and comply with applicable GCP and GVP regulations.
The course will guide you through the different assays needed (ligand binding and cell based assays) in each process step and how to set them up and validate them under the current regulatory documents and with regards to GLP/GCP/GMP.
The delegates will be provided with information concerning a Safety Department they have been asked to audit. The safety department in question is the Company Headquarters Safety Department based in the EU.
The current GXP regulations focus more and more on the topic of risk management in CSV. This seminar will provide you with guidance in carrying out risk assessments when validating computerized systems.