C | B
Qualifications
Excerpt of further training courses I have attended
GxP
- GMP Auditor
- Audits and self-inspections
- Integrated Quality Systems
- Qualification and validation
- Incidents, deviation management and CAPA
- Change control (inspector's expectations for GMP compliance, change control in project processing, change control in quality agreements)
- Risk management
- PQS (ICH Q9 and Q10) - knowledge management / risk management as part of PQS
- Good Documentation Practice
- GMP systems
- GMP of ATMPs and exipients (requirements for manufacturing and quality control of ATMPs, qualification and monitoring of contract manufacturers/laboratories, requirements for exipients, qualification and monitoring of exipient manufacturers, import of products from non-EU countries, ICH Q8 and Quality by Design)
- Batch record review and release
- Active ingredients and GDP
- GMP and GDP Vendor Qualification & Management
- Requirements for drawing up contracts (regulatory basis for manufacturing and testing in contract manufacturing, comparison of QM elements, legal requirements, requirements for contracts in the GMP environment, QAA, QTA)
- Regulatory principles for research and development, implementation of QM elements for product and data safety, from PSF to CTD
- GMP regulations, quality assurance and quality management, documentation, quality/GMP requirements for quality control, production and process validation under GMP
- Pharmacovigilance in clinical research
- Responsibilities and tasks in clinical trial management at the interface of GMP and GCP
- GCLP - EMA Reflection Paper on GCLP and regulatory compliance of diagnostic laboratories involved in clinical trials
- GCP - Declaration of Helsinki, ICH Process and Principles, ICH-GCP
- GCP - regulatory update EudraLex and EudraCT, EU regulation on clinical trials, data protection and transparency, GCP and AMG, GCP with ATMP, risk based QM and monitoring, IMPs in IITs, handling of source data and eCRFs
- GCP - ICH-GCP Working with CROs, EU Legislation, AMG and GCP Regulation
- GCP - ICH-GCP, EU Clinical Trials Directive, GCP regulations
Computer System Validation
- Computerized System Validation and Data Integrity in Pharma & BioTech
- GxP CS Auditing
- Auditing Computerized Systems
- GxP compliance in cloud infrastructure
- Electronic Signatures / Biometric Signatures
- GAMP5
- GMP-compliant document management using an electronic system
- GMP-compliant test equipment management systems
- Computerized System Validation - Risks, Requirements Tests and Tracebility
- CSV Awareness - Change and Error Management
- IT - QA Compliance
- Computerized system validation in practice
- Computer System Validation (Regulations EU, USA, RoW, CSV Process)
ISO & MedTech
- ISO 13485 and MDR
- ISO 19011 Internal Auditor
- ISO 62304 Medical device software - Software life cycle processes
- ISO 14791 Application of risk management to medical devices, Risk management and risk analysis for medical devices
- ISO 10993 Biological evaluation of medical devices - Evaluation and testing within a risk management process
- ISO 62366 Application of usability engineering to medical devices
- Medical Device Single Audit Program (MDSAP)
- Responsible person according to Article 15 MDR - Person Responsible for Regulatory Compliance (PRRC)
- Medical Device Regulation (MDR) - Implementing requirements in quality management
- Supplier management for medical devices
- Quality and risk management for medical technology
- Risk management for cyber security according to MDR
- Cyber security - IT security for medical devices
- The requirements for CE marking of medical devices in the EU
Data protection
- Data protection in medicine
- Information security and GDPR compliance
- Data protection officer according to GDPR
- The data protection regulation (GDPR)