ECA Certified GMP Auditor
Heidelberg, Germany
1. ECA Certificate– Live Online Training- Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals
(Heidelberg, Germany/ Oct. 2021 )
- Overview of stability programs and definition of storage label statements
- Mean Kinetic Temperature (MKT) and World climatic zones
- Stress studies of pharmaceuticals
- Stability studies to support shipping/distribution of pharmaceuticals and biopharmaceuticals
- Investigation of excursions from storage label conditions
- Evaluation of excursions
2. ECA Certificate– GMP for Medical Devices
(Berlin, Germany/ Oct. 2019 )
- Similarities/differences between Medicinal Products and Medical Devices
- Certification Procedures under the European MDR
- Differences between European and US Requirement
- Classification and Premarket Submission of Medical Devices in the USA
- GMP- related Requirements of EN ISO 13485-2016
- Combination Products
- Regulatory Audits under MDR and MDSAP
3. ECA Certificate– GMP meets GDP
(Berlin, Germany/ Nov. 2017 )
- Storage – Temperature Mapping, Transport and Logistic
- European Regulatory Requirements and Guidance
- Best practices in Storage
- Best practices in Transport and Logistic
- Shipping Stability
- Cold Chain
- Supply Chain Security
4. ECA Certificate– The GMP-Auditor
(Praha, Czech Republic/ Oct. 2017 )
- How to optimize the audit programme
- How to plan an audit
- How to become a good auditor
- Top 10 Mistakes Auditors make and how to avoid them
- Audit types/ The challenge of appropriate communication
- How to recognise, understand and solve conflicts
- Body Language and Questioning Techniques
- Suppliers from China, India and South America
5. ECA Certificate- Efficient Supplier Qualification
(Vienna, Austria/ May 2017 )
- Qualifying and maintaining Suppliers
- GMP Pre-requisites for Procurement and Outsourcing activities (Contract Manufactures and Laboratories)
- International Trade Relations
- Regulatory Inspections
- Frequency of Supplier Audits based on Risk Assessment
- Reduced Testing of Supplied APIs and Excipients
6. ECA Certificate- Suppliers from China and India
(Vienna, Austria/ May 2017 )
- Sourcing from Asia: what Procurement and QA should know
- The Indian and Chinese Pharma Markets (legal Structures, Authorities, cultural aspect to consider when doing Business)
- Auditing in India and China – Supply Chain Risk Assessment
Qualified Person Certificate (QP)
- Certified issued by NAMMDR (National Agency for Medicines and Medical Devices of Romania)
(Mar. 2012 )
PHARMA-GMP-AUDIT-CONSULTING 