Andreas Kalanzis

Independent Consultant for auditing and consultancy for GxP-themes according EU GMP-Leitfaden Annex 11, US Code of Federal Regulations, Title 21 Part 11. PIC/S PI 011-3 Good Practices for Computerised Systems In Regulated Gxp Environments ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems Current Annex 1 Risk Assessment and CCS implementation Independent Consultant as negotiator and Auditor for work council agreements for CS (BDSG, BetrVG)

Building up the QMS of the manufacturer as well as creating Validation Plan and validate with company empoyees the first GMP compliant Lab Equipment. Ongoing support for GMP and CSV topics.

Quality Strategy, Quality Systems, Quality Compliance EU and US, Inspections, Peoples Q-Mentality, Budget Q-Organisation, Communication Internal-External, Training Annex 1 in English and German, RA according to Annex 1 vs. older Versions implemented on site. CCS according Annex 1. SOPs for sterile Biologics especially for QC (APS and VI), Facility-specific germ Database.

Closing Gaps at the Quality Management System of STADA/Mobilat GmbH and train employees in GMP and CSV for the upcoming authority inspection.

Closing Gaps at the Quality Management System of STADA/Mobilat GmbH and train employees in GMP and CSV for the upcoming authority inspection.

Assessing the potential Risk of medicinal products containing chemically Synthesized APIs for N-Nitrosamine Impurities of all Novartis and affiliates portfolio.

API importation from India and Korea over US as well as further processing till EU QP release of the finished product. Distribution in the EU. Strategy and project plan of the potential Side movement.

Responsible for all processes around the Central Warehouse, the shipping lanes worldwide, shipping qualifications, affiliates relations, external partner relations such 3PL, wholesalers, distributors. Conducting GDP audits worldwide and following up Logistic and Security issues. Also responsible to and successfully improve and increase robustness for all Computerized Systems related to the logistic and commercial part such interfaces with partners, Biogen CSs, Master Data.

Performing GMP and CSV&C corporate audits as a lead auditor. Performing Supplier Audits for Supplier Qualification. Responsible QA Person to release Corporate Computerized Systems in terms of Validation and Part/annex 11 Compliance. Implementation of the Corporate Policy on Computer Systems Validation and Compliance (CSV&C). Coordination of international Teams to develop and design Corporate Computerized Systems. Interpretation of international Requirements, Guidance’s, Guidelines to CSV&C.

Supplier Qualification and Self Inspections at Pharma and Chemicals area.

Bach Record Review, Errors and Deviations Handling, Final Release. Develop, validate and implement a Database for handling of Errors, Deviations, and Changes at two German sites with more then 500 users. Part Project Leader at the SAP Implementation.