Labcompliance

This seminar will discuss how to effectively implement GMP regulations in quality control laboratories for FDA and EMA compliance.

This seminar will discuss how to use modern lifecycle management and quality by design principles to ensure method robustness for easy transfer and to avoid OOS situations

This seminar will give an overview on ICH Q3D and USP approaches to specify and control elemental impurities to below toxic limits in drug products and ingredients. The seminar will discuss in detail selected elements, limits and analytical procedure

This web-seminar will discuss how to set parameters and acceotance limits for system suitability testing of chromatographic and other methods

This web-seminar is designed as introductory training on GMPs for new employees and as refresher and update training for everybody working in FDA GMP and equivalent international environments

This seminar will discuss how to manage Out-of-Trend (OOT) results for FDA compliance.

This web-seminar will discuss how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies.

This web-seminar will discuss requirements and strategies for cost-effective qualification of IT Infrastructure and Network in FDA regulated and international environments. Attendes will receive 10+ best practice guides for easy implementation.

This web-seminar will discuss how to prepare Pharmaceutical companies marketing products in Europe for upcoming Annex 11 inspections. Attendes will receive 10+ best practice guides for easy implementation.

This web seminar will discuss how to how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies. Attendes will receive 10+ best practice guides for easy implementation.