Highest Priority: Patient Safety
International Audits
GDP Audits at Suppliers and Service Providers
- Pharmaceutical Wholesalers
- Pharmaceutical Companies
- Third Party Logistic Providers (3PLs)
Focus
- Security of the Supply Chain
- Temperature-controlled Transports
- Supplier-Qualification
Inspection Preparation
Assistance in obtaining and maintaining a pharmaceutical wholesale license / GDP certificate
- Establishment and review of processes for the submission to the regional council
- Adaptation to the current legal requirements (GDP, AmHandelsV, AMG)
- Provision of all required documents for the submission
- Execution of Mock-Inspections
Contracted Responsible Person Wholesale
Flexibility and efficiency combined with GDP Compliance
- Qualification as Responsible Person Wholesale (RPW)
- Information Officer
Validation and Qualification
Comprehensive, understandable and adapted to your needs
- Transport Validation
- Warehouse Qualification
- Supplier and Customer Qualification
Methods
Detailed knowledge of the requirements leads to concentration on the essentials.
Analysis of Requirements
Stakeholder and Solution-oriented Implementation of Requirements
Implementation of understandable and robust Processes
Performance Review
References
Contracted Responsible Person Wholesale
for a Bitotech Company in Munich, monitoring the Initial Inspection
Advising a Pharmaceutical Company for the
Pre-inspection Submission
at the Regional Council
Implementation and Validation
of the Software for the Fulfillment of the EU Counterfeiting Directive for a Pharmaceutical Wholesaler with a focus on drug imports
Warehouse Qualification and Transport Validation
for frozen (-25 °C ... -15 °C) Pharmaceuticals for a Pharmaceutical Wholesaler
ISO 9001:2015
Certification of an IT-Service Organisation
Teaching and Lectures
PKA - Congress
Lecture for the Bayerische Landesapothekerkammer, 21.11.20
Temperature Monitoring in Pharmacies
Seminar for the Apothekerkammer Nidersachen, 31.08.20 - 08.10.20
Temperature Monitoring in Pharmacies
Webinar for the Apothekerkammer Schleswig-Holstein, 07.05.20
Counterfeit Pharmceuticals and the Security of the Supply Chain
Seminar for the Ludwig-Maximilians Universität München, 19.12.19
Teaching Pharmacology
at the Schwesternschaft des Bayerischen Roten Kreuzes München, 27.11.19 und 18.12.19
Quality Management / Risik Management / Audits / Serialisation / Transport Validation
Lecutre for the Technische Hochschule Rosenheim, Oktober 2019
Drug Safety - the Background of Securpharm
Webinar for the Bayerische Landesapothekerkammer, 23.09.19
Temperature Monitoring in Pharmacies
Webinar for the Bayerische Landesapothekerkammer, 12.09.19
Teaching Pharmacoloy
at Schwesternschaft des Bayerischen Roten Kreuzes München, 16.07.19 und 18.07.19
Delivery bottlenecks in Germany and initial experiences with Securpharm
Lecture for the Landesapothekerkammer Thüringen, 2019
Teaching Pharmacology
at the Schwesternschaft des Bayerischen Roten Kreuzes München, 19.03.19 und 21.03.19
Counterfeit Pharmceuticals and the Security of the Supply Chain
Seminar for the Ludwig-Maximilians Universität München, 30.01.19
Temperature Monitoring in Pharmacies
Webinar for the Bayerische Landesapothekerkammer, 23.10.18
Quality Management / Risik Management / Audits / Serialisation / Transport Validation
Lecutre for the Technische Hochschule Rosenheim, Oktober 2018
Career
| 2019 | Self-employed Consultant |
| 2014 – 2018 | Quality Manager |
| 2013 – 2014 | Manager for Export and Clinical Trials Supply |
| 2012 | Medical Advisor |
| 2005 – 2012 | Working in Pharmacies |
| 2001 – 2005 | Studies of Pharmacy |
- Author
- Speaker: LMU Munich, TH Rosenheim, BLAK, LAKT
- Founder Schoendiener GmbH
Publications
- Book — Temperaturfibel für Apotheken – Arzneimittel richtig lagern und transportieren
Concept and background to implement a solid temperature monitoring for pharmacies
Published: December 2018, Govi Verlag - Title Article — Lagertemperaturen: Kontrolle spart Zeit und Geld
Pharmazeutische Zeitung, Issue 47/2016
Career
| 2019 | Self-employed Consultant |
| 2014 – 2018 | Quality Manager |
| 2013 – 2014 | Manager for Export and Clinical Trials Supply |
| 2012 | Medical Advisor |
| 2005 – 2012 | Working in Pharmacies |
| 2001 – 2005 | Studies of Pharmacy |
- Author
- Speaker: LMU Munich, TH Rosenheim, BLAK, LAKT
- Founder Schoendiener GmbH
Publications
- Interview — Diese Apothekerin macht Kollegen hitzefest
Published: July 2019, apotheke adhoc - Book — Temperaturfibel für Apotheken – Arzneimittel richtig lagern und transportieren
Concept and background to implement a solid temperature monitoring for pharmacies.
Published: December 2018, Govi Verlag - Title Article — Lagertemperaturen: Kontrolle spart Zeit und Geld
Pharmazeutische Zeitung, Issue 47/2016