Curriculum Vitae. Lone Cleveland Andersen. Courses

Transcription

1 Courses and continuing education, listed by subjects. GMP courses API Curriculum Vitae Lone Cleveland Andersen Courses ICH Q7; Compliance for API s manufactured by cell culturing and fermentation, European Compliance Academy, Copenhagen, 2 days API handling and inspections, DHMA, 1 day Active Pharmaceutical Ingredients, Daniel Gold, Novo Nordisk A/S, 2 days Aseptic production Risk Management of Aseptic / terminally sterilized production, IFF Copenhagen, 1 day (2015) Understanding Pharmaceutical Sterilization, Compliance & Validations Services Ltd.; Amsterdam, 3 days. Environmental Monitoring, European Compliance Academy, Copenhagen, 2 days Seminar re. Millipore filters, DHMA, 1 day Freeze-drying equipment and processes, Scantago and DHMA, 1 day Theme; clean rooms, Dansk Standard and DHMA, 1 day Monitoring clean rooms, Holm & Halby and DHMA, 1 day Physical particle characterization, Particle Analytical and DHMA, 1 day Aseptic production, Novo Nordisk A/S, 1 day Validation of clean rooms, Novo Nordisk A/S, 1 day Practical microbiology, Novo Nordisk, 2 days Millipore filters, Novo Nordisk, 1 day FDA and European GMP Compliance for cleanrooms and how the best to meet it, European Compliance Academy, Copenhagen, 2 days Manufacturing and validation of sterile medicine, Pharmakon, Hilleroed, 3 days Audit and contract manufacturing Contract manufacturing, Pharmakon, Hilleroed, 1 day Internal audits and quality audits, Pharmakon, Hilleroed, 2 days GMP Compliance Auditing, John Lee, Novo Nordisk A/S, 2 days Batch records Batch Records Review and Investigation, John Lee, Novo Nordisk A/S, 2 days Biotech and cell cultures Biotechnology for Non-Biotechnologists, European Compliance Academy, Berlin, 2 days ICH Q7; Compliance for API s manufactured by cell culturing and fermentation, European Compliance Academy,2 days GMP compliance for Biopharmaceuticals, API manufacturing, Novo Nordisk A/S, 2 days Active Pharmaceutical Ingredients, Daniel Gold, Novo Nordisk A/S, 1 day 1

2 Change Control Change Control, Novo Nordisk A/S, 1 day Change Control procedure, Novo Nordisk A/S, ½ day Deviations and CAPA Non Conformities Handling, Novo Nordisk A/S, 1 day Introduction to A2DB - non conformity IT database, Novo Nordisk A/S, 1 day General GMP GMP updates 2015, IFF Copenhagen, 1 day (2015) Physical particle characterization, Particle Analytical and DHMA, 1 day Non-sterile Drug Products, GMP Compliance & Education, Copenhagen, 2 days Handling alarms and interventions, Novo Nordisk A/S, 1 day GMP in Global Support, module 1 & 2, Novo Nordisk A/S, 2 days GMP compliance, European Compliance Academy, Copenhagen, 2 days Are your systems in compliance with 21 CFR part 11, Pharmakon, 2 days Safety requirements of physical and IT based batch documentation, Novo Nordisk A/S, 1 day Quality improvements in Production, Conference in London, 2 days GMP og communication, Pharmakon, 3 days Quality Mind-set, Novo Nordisk A/S, 1 day GMP for academics and specialists, Novo Nordisk A/S, 2 days Several professional GMP training days, DHMA, 25 days Inspection GMP Compliance Auditing, John Lee, Novo Nordisk A/S, 2 days Preparing a FDA inspection, John Lee, Novo Nordisk A/S, 2 days FDA Pre- and Post-approval inspections, Pharmakon, 2 days IT systems EU GMP, Annex 11; inspection of computer systems, DHMA, 1 day Computer Validation: Maintaining Control of Operation, European Compliance Academy, Barcelona, 2 days Diamant, specialized registration system, DHMA, 1 day Training in Diamant system, DHMA, 1 day Diamant pilot training, DHMA, 1 day Guidelines directions for GoPro archive ring system, DHMA, ½ day ISOTrain, Training Coordinator Course, Novo Nordisk A/S, 1 day COCPIT; handling and register of customer complaints, Novo Nordisk A/S, 1 day QBIQ; main use of UserAR2 database, Novo Nordisk A/S, 1 day Introduction to DBEIS System, internal IT, Novo Nordisk A/S, 1 day HC*LIMS, Analytical result system, Novo Nordisk, 1 day Introduction to A2DB - non conformity database, Novo Nordisk A/S, 1 day 2

3 Laboratories Latest regulations/guidelines, inspection and enforcement trends for FDA s CFR Part 11 in pharmaceutical laboratories, Agilent Technologies, Copenhagen 1 day Registration Drug / Device Combination Products GMP for combinations product, Pharmakon, 1 day (2015) Regulatory Approval of medicine (authorities), DHMA, 1 day Approval of drugs, Pharmakon, 1 day Costumer Complaints Handling of Costumer Complaints in COCPIT IT system, Novo Nordisk A/S, 1 day Risk Management Quality Risk Management Part III, Pharmakon Hilleroed, 1 day Risk Management in Sterile Manufacturing, European Compliance Academy, Copenhagen, 2 days Risk and Science based Manufacturing (Powder & tablets), ISPE, Copenhagen, 1 day Excipients and suppliers GMP for Excipients, European Compliance Academy, Copenhagen, 2 days Environmental and social evaluation of Suppliers, Novo Nordisk A/S, 1 day Qualified Person, QP The role of QP, IFF Copenhagen, 1 day (2015) European Compliance Academy, conference: 3rd Annual Qualified Person Forum, München, 2 days European Compliance Academy conference: 2nd Annual Qualified Person Forum 2007, Berlin, 2 days QP networking and experience, Pharma Danmark, ½ day Statistics Introduction to statistics for academics, Novo Nordisk A/S, 2 days Practical statistics for academics, Novo Nordisk A/S, 2 days Main statistics, Novo Nordisk A/S, 1 day Statistics seminar, Novo Nordisk A/S, 2 days Validation FDA s new approach to Process validation, NNE Pharmaplan, 1 dag Quality by Design and Analytical Methods, DHMA, 1 day Cleaning and Cleaning Validation, Compliance & Validations Services Ltd., Amsterdam, 3 days Design Space og PAT, DTU Kemiteknik, 2 days Cleaning Validation, Rebecca Brewer, Novo Nordisk A/S, 2 days Manufacturing and validation of sterile drugs, Pharmakon, 3 days 3

4 GDP GDP latest news New Guidance, Pharmakon Hilleroed, 1 day Global Supply Chains, PIC/S seminar, Ottawa, 3 days. Training and interpretation of the new GDP guideline, DHMA, 1 day GDP news; new GDP guideline, Pharmakon, 1 day PIC/s seminar; Good Distribution Practise, Krakow, 3 days GCP GMP meets GCP, European Compliance Academy, Copenhagen, 2 days Pharmacovigilance 2012 EU Pharmacovigilance Training Course, Copenhagen, 3 days Pharmacovigilance Inspectors Work Group (PhV IWG) Training, EMA, Antwerp, 3 days PHV IWG meeting in EMA-London, 1 day EMA-London: Training in Pharmacovigilance database Eudravigilance, 1 day Pharmacovigilance introduction, Pharmakon, 1 day QA in Pharmacovigilance Post marketing & Clinical Trials, Pharmakon, 2 days Pharmacovigilance GMP/GCP, DHMA, 1 day Several professional Pharmacovigilance training days, DHMA, 2 days Project Management and Management Project management, module 2, Novo Nordisk A/S, 5 days Project management, module 2, Novo Nordisk A/S, 5 days KREA manager; creative processes for management, Krea Consult, 2 days Advanced Power 2 Influence, module 2; personal development and management, Learn 2 Lead, 4 days Supply Professionals Academy module 1-3, business relations and project management, Novo Nordisk A/S, 6 days Advanced Power 2 Influence module 1; personal development, Learn 2 Lead, 4 days Process planning and mapping of business processes, Force Technology, 2 days Certified Auditor/Lead Auditor examination, BSI Training Service, 5 days Labour legislation for managers, module 1-5, Novo Nordisk A/S, 5 days Blood legislation Serology, Blood bank, Naestved, 2 days HCV, Dansk Transplantationsselskab, ½ day PIC/S seminar Tissues, cell and blood, Copenhagen, 4 days NAT analysis, Henrik Ullum, Rigshospitalet, DHMA, 1 day Several professional training days in blood and tissue, DHMA, 2 days 4

5 ISO DANAK assessor, DS/EN ISO standard for laboratories, 3 days Certified Auditor/Lead Auditor examination, BSI Training Service, 5 days Training for internal auditors, DHMA, 1 day Process planning and mapping of business processes, Force Technology, 2 days Update of DS/EN ISO 9001:2000 standard, Force Technology, 1 day ISO training and preparation for audits, Novo Nordisk A/S, 1 day Introduction to DS/EN ISO 9000, Force Instituttet, 2 days DS/EN ISO 9000 standard, Novo Nordisk A/S, 2 days LEAN clean; LEAN tools, Novo Nordisk A/S, several modules, 6 days clean main course, Novo Nordisk A/S, 1 day (Other courses) Deception, how to cope (police), DHMA, 1 day Conference for staff in DHMA, 1 day Rules for employees in DHMA, 2 days Written communication, DHMA, 1 day Doc2000, Internal IT course, DHMA, 1 day LOS; how to handle internal company information s, DHMA, 1 day Introduction for new employees, DHMA, 1 day The quality system, DHMA, 1 day Unwritten rules of career, DIEU, 2 days Market Awareness French culture, Novo Nordisk A/S, 1 day Market Awareness Japanese, culture, Novo Nordisk A/S, 1 day Market Awareness Brazilian culture, Novo Nordisk A/S, 1 day Market Awareness American culture, Novo Nordisk A/S, 1 day Outlook 2000, Novo Nordisk A/S, 1 day Presentation technique, Novo Nordisk A/S, 1 day Firefighting Novo Nordisk A/S, ½ day Effective communication and collaboration, Teknologisk Institut, 3 days Report writing skills, advanced level, Novo Nordisk A/S, 3 days Internet for pharmaceuticals, Pharmakon, 1 day Word Perfect to Windows 5.2; Novo Nordisk A/S, 1 day Introduction for new employees, Novo Nordisk A/S, 1 day Advanced English, Novo Nordisk A/S, 1 day 5