Topics Gap analysis, CAPA and Train-the-trainers
Pre-reading materials
- 3947-5999-1-pb.pdf
- 8-impact-of-training-and-development-on-organizational-performance.pdf
- bp_ep_methods_of_sterilisation_xviii_2011_copy.pdf
- fda_guide_aseptic_final_9-04_copy.pdf
- hpfb_guide_-0023_audit_2012.pdf
- hsa_autoclave_guide-mqa-011_copy.pdf
- ich_q10_guideline.pdf
- ich_q9.pdf
- j_gxp_c_continuing_10_09.pdf
- pics_pi-023-2-inspection_qc_labs.pdf
- paper_20.pdf
- reaching_international_gmp_2009.pdf
- s18.pdf
- sterilisation_definitions_f0_tables_copy.pdf
- tga_deficiency_categories.pdf
- usp_1116_em_for_aseptic_processing_copy.pdf
- TRS1044 Annex 2 GMP for Sterile Pharmaceutical Products
Presentation materials
- cbe_-_023_v3_environmental_monitoring_programs_.pdf
- cbe_-_100_v2_preparation_for_regulatory_audits.pdf
- cbe_-_101_v2_internal_audits_how_to_.pdf
- cbe_-010_pqs_ich_q10_v4_1_.pdf
- cbe_-013_risk_management_v3.pdf
- cbe_023_cleanroom_management_qualification.pdf
- cbe_040_gap_analysis_v3.pdf
- cbe_106_heat_sterilisation_v4.pdf
- cbe_107_aseptic_processing_v2.pdf
- Martin Ginty – Intro to humidity from customer problem perspective
