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

 

Temperature Monitoring in Pharmacies

Webinar for the Apothekerkammer Schleswig-Holstein, 07.05.20


Temperature Monitoring in Pharmacies

Seminar for the Apothekerkammer Nidersachen, 18.03.20 - 24.04.20


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

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

Contact me!