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

Interims Contracted Responsible Person Wholesale

for a Generic Drug Manufacturer in Hallbergmoos

Quality Manager, external

for a Pharma Start-up in Munich

Quality Manager, external

for a Biotech Company in Munich

Interims Contracted Responsible Person Wholesale

for a Generic Drug Manufacturer in Gröbenzell

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

Teaching and Lectures

Counterfeit Pharmceuticals and the Security of the Supply Chain

Seminar for the Ludwig-Maximilians Universität München, 09.02.2023

Quality Management / Risik Management / Audits / Serialisation / Transport Validation

Lecutrer for the Technische Hochschule Rosenheim, WS 22/23

 

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!