Scientific Consulting
Dr. Petra Keiner
Education
Diploma Chemistry (1989)
Philipps University Marburg, Germany
Doctoral degree (Dr. rer. nat., 1994)
Philipps-Universität, Marburg
Julius-Maximilians-University, Würzburg
Georg-August-University, Göttingen
all Germany
Developer for ORACLE database systems (2002) CDI, Mannheim, Germany
Professional Experience (Consultant)
Clinical Research Associate (CRA), Medical devices
MDR / IVDR Compliance, Classification of Medical devices
Validation / Qualification of processes for clinical trials (Medical devices)
Design of data evaluation software for clinical trials (Medical devices)
Special Experience
Clinical Chemistry
Specialized Analysis for Metabolic Diseases
Further Courses, Seminars (Selection)
Prüfkurs (gem. MPG) Klinische Studien für Medizinprodukte, MSZ, Münchner Studien Zentrum
ISTQB Certified Tester Foundation Level Training, EXCO GmbH, Frankenthal
Certified Curricula (Selection)
Modular Quality Management System (MQMS)
MQMS GxP
MQMS Quality Management System Fundamentals
MQMS Study Processes Basic
MQMS Study Processes Expert
MQMS Clinical Development Expert
MQMS Compliant & Ethical Conduct Studies Expert
MQMS Design and Development Expert Training Product Risk Management
MQMS Clinical Evidence & Studies (CES) Module - Biometrics Basic
MQMS Regulatory
MQMS Expert Training Defect Management
MQMS CHGCTL Change Control Experte
Certified Curricula (Selection)
Clinical Development and Medical Affairs (CDMA)
CDMA IVDR and ISO 20916 Regulations
CDMA Introduction to the principles of ISO 14155
CDMA Outsourcing Center of Excellence
CDMA Clinical Documentation Tools and Strategy
CDMA Clinical Operations Risk Based Monitoring
CDMA Document Development Process
CDMA Study Report Requirements!
CDMA Study Risk Assessment
CDMA Study Types and Roles
CDMA Roles and Responsibilities
Certified Curricula (Selection)
Clinical Trial Management System (CTMS)
CTMS Veeva Vault Clinical
CTMS Veeva Vault Clinical Data
CTMS Medrio Electronic Data Collection (EDC) Data Entry Training
CTMS Medrio EDC - Basic Navigation
CTMS Medrio EDC - Site Data Entry
CTMS Medrio EDC - Data Review
CTMS Basic eTMF Navigation
CTMS eTMF Edit User
CTMS eTMF View User
CTMS eTMF External Inspector
CTMS Managing Sites and Subjects
CTMS Accessing Reports in Vault
CTMS Monitoring Visits
CTMS Managing Sites and Subjects
CTMS Accessing Reports in Vault
CTMS Monitoring Visits
CTMS Site Management
CTMS Inventory Management
Certified Curricula (Selection)
Regulations, Standards
DIN EN ISO 9001:2015, Quality management systems - Requirements
Din EN ISO 14155:2020, Clinical investigation of medical devices for human subjects - Good clinical practice
DIN EN ISO 14971:2019, Medical devices - Application of risk management to medical devices
DIN EN ISO 15197:2013, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purpose
MDR, Medical Device Regulation
IVDR, In Vitro Diagnostic Regulation
ICH GCP, International Conference on Harmonization - Good Clinical Practice