• Newsroom
  • Join us!
  • Newsletter
  • Kontakt
  • English English English en
  • Deutsch Deutsch German de
Experts Institut
  • Business Consulting
    • Business Solutions
      • Digitization
      • Sustainability Corporate strategy
      • Management systems
      • Project management
      • Strategy & Performance
      • Transformation & Leadership
  • GXP Consulting
    • GMP Beratung
      • Audits & inspections
      • GMP/GXP training courses
      • GMP Aircheck4
      • Continuous Manufacturing
  • Industries
    • Pharma
    • Service providers & trade
    • Automotive
    • FOOD & BEVERAGES
    • Financial service providers & insurances
    • Informationstechnik (IT)
    • Aerospace
  • Academy
    • Individuelle Inhouse-Schulungen
      • GMP/GXP training courses
    • Experts Institut Events
      • Academy
    • Direkt buchen
      • Live-Events
      • On-Demand Webinar
  • Kunden
  • Über uns
    • Über uns
      • Guideline
      • Portrait
      • Team
      • Geschäftsführung
      • Vision
      • Events
      • History Experts Institute
      • Sustainability at the Experts Institute
      • Social responsibility
    • Wissen
      • GMP Glossary
      • FAQ – Frequently asked questions in the GMP environment
      • Videos
    • Blog
      • Newsroom
  • Click to open the search input field Click to open the search input field Search
  • Menu Menu
  • Link to LinkedIn
  • Link to Xing
Uncategorized

Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge. This is one reason why many would assume that the entire world can be talked to, related to and understood quite readily. It is part of everyday work for many after all—or so we think.

In the area of audits and inspections, crossing cultures happens all the time. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings.

This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete—in other words, that has boundaries. It is simply impossible for one person to really become multicultural—our lifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.

So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.

And now it gets interesting: This problem includes audit and inspection situations!

Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.

Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.

From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.

An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.

As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies—even the judgment on severeness.

If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…

This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.

How can You improve?

– Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.

– Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.

– Respect that standards—even GMP—can be lived effectively in different ways.

– Open to the truth that You do not know everything best.

Want to know more? Ask for cross-cultural factor training for auditors and inspectors @ExpertsInstitut.

We can help You. And after this You will never be the same. You will be a better auditor. You may—in fact—be a better You. Yes – really.

30. July 2024/by Dr. rer. nat. Dietmar Gross
https://experts-institut.com/wp-content/uploads/2024/07/1721830906970.jpeg 720 1280 Dr. rer. nat. Dietmar Gross https://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webp Dr. rer. nat. Dietmar Gross2024-07-30 09:14:342024-07-30 09:15:44Crossing Cultures in Audits and Inspections
Retaxation

Retaxation – a lucrative instrument for health insurance companies

-Blog post on the subject of retaxation

Retaxations in pharmacies mean that the health insurance companies reclaim money that they have previously paid to pharmacies for the dispensing of medicines. This usually happens up to 15 months after the drug has been dispensed. This is particularly lucrative for health insurance companies, for example in the case of pharmacies that manufacture cytostatics. Cytostatic drugs are chemotherapy drugs that are used to treat cancer. Pharmacies produce these medicines in special laboratories according to the doctor’s instructions and in compliance with strict regulations. This production is always adapted to the individual patient.

With regard to the retaxation of cytostatic drugs, this means that health insurance funds check whether the dispensing and billing of these drugs by pharmacies has been carried out properly and whether all regulations have been complied with. If this is not the case, the health insurance company can demand money back and often uses this simply as a prophylactic measure to reduce the funds. In most cases, this is due to formal errors in the prescription (e.g. pink prescription issued by the doctor) or the billing of wastage (remaining quantities of the medicine required for production).

Retaxations can be very costly and economically ruinous for pharmacies and are often the subject of controversy and discussion between pharmacies and health insurance companies. However, pharmacies often lack the staff, time and expertise to process the mountain of retaxations and to draw up appeals with all the supporting documents in good time.

Retaxation

Strategies for avoiding retaxations

  1. Careful documentation: Precise and complete documentation of all processes, from prescribing to dispensing the medication, can help to avoid errors and maintain an overview.
  2. Ongoing training: Regular training of pharmacy staff on current regulations and billing practices can help eliminate common sources of error.
  3. Proactive communication: A close exchange with doctors and health insurance companies can prevent misunderstandings and clarify problems at an early stage.

This is where we, the Experts Institut, come in with our special retaxation service. Since 2008, we have been supporting pharmacies in taking professional and effective action against unjustified retaxations by health insurance companies. With our expertise and experience, we offer tailor-made solutions that relieve pharmacies of staff and help to minimize economic losses.

Please contact us for further information: info@expertsinstitut.de

Get ahead and in touch with us

Your Experts Institute Team

#pharmacies #retaxation #healthcare #drugs #pharmacy #health insurance #cytostatics #dispensing #billing #pharmaceutical consulting #pharmacy management #healthcare policy #pharmacy practice #drug manufacturing #PharmacistLife

16. July 2024/0 Comments/by Fabienne Grieger
https://experts-institut.com/wp-content/uploads/2024/07/9.jpg 1080 1920 Fabienne Grieger https://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webp Fabienne Grieger2024-07-16 09:12:132024-07-16 09:13:00Retaxation – a lucrative instrument for health insurance companies
Recent
  • Business Continuity
    Business continuity management: How companies strategically...4 weeks 
  • Continuous Manufacturing
    Continuous manufacturing: future trend in the pharmaceutical...2 months 
  • Qualitätsmanagement
    How to create an effective quality management system (QMS)...31. July 2025 - 10:39
  • Informationssicherheit
    ISMS 2024: What companies need to know now about NIS2, DORA,...3. July 2025 - 12:32
Popular
  • Cultures in Audits & Inspections
    Crossing Cultures in Audits and Inspections30. July 2024 - 9:14
  • Cultures in Audits & Inspections
    Crossing Cultures in Audits and Inspections1. August 2024 - 9:38
  • English
    Quality Management Maturity: The Importance of Good English...22. August 2024 - 12:43
  • VSME-Standard für KMU
    Combining sustainability and success: The new VSME standard...4. September 2024 - 12:06

Tags

AI AI Annex Annex 11 Artificial Intelligence Audit audits Business Continuity Management Cannabis Certification Clean room Computerized systems Continuous Manufacturing CRA Cultures Cytostatics Data Integrity DORA Draft Germ count Germ count monitoring GMP GXP Health insurance Information security inspections ISMS ISO/IEC 42001 ISO 9001 ISO 27001 ISO standard Laboratory Machine Learning NIS-2 NIS2 Pharmacy QMS Quality management system Reagents Regulations Retaxation Sustainability Transformation

Kategorien

  • Business Solutions
  • GMP
  • GXP
  • News
  • Retaxation
  • Sustainability
  • Uncategorized

Archiv

  • October 2025 (1)
  • September 2025 (1)
  • July 2025 (2)
  • March 2025 (1)
  • January 2025 (1)
  • December 2024 (1)
  • November 2024 (1)
  • October 2024 (3)
  • September 2024 (2)
  • August 2024 (2)
  • July 2024 (2)
  • May 2024 (1)
  • April 2024 (2)
  • March 2024 (2)
  • February 2023 (10)

Webpräsenz der Allianz für Cyber- Sicherheit
kununu widget

Business Solutions

  • Digitization
  • Sustainability
  • Management systems
  • Project management
  • Strategy & Performance
  • Transformation & Leadership

GMP / GXP Consulting

  • GMP Consulting
  • GMP audits & inspections
  • GMP/GDP training courses
  • GMP/pharmaceutical engineering
  • Continuous Manufacturing

EI Academy

  • GMP / GxP
  • Academy
  • Live events
  • On-demand webinar

New town

Experts Institut Beratungs GmbH
Weinstraße 85

D-67434 Neustadt a. d. Weinstraße

Phone: +49 (0)6321 969210
E-mail: info@expertsinstitut.de

Fax: +49 (0)6321 9692199

Bamberg

Experts Institut Beratungs GmbH
Untere Sandstraße 53

D-96047 Bamberg

Phone: +49 (0)951 51939330
E-mail: info@expertsinstitut.de

St. Gilgen (Austria)

Experts Institut Beratungs GmbH
Helenenstraße 16

A-5340 St. Gilgen, Austria

Tel.: +43 (0)6227 21068
E-Mail: info@expertsinstitut.de

  • Link to LinkedIn
  • Link to Xing

© 2024 Experts Institut Beratungs GmbH
  • Imprint
  • Data protection
  • AGBs
  • Cookie Directive (EU)
Scroll to top Scroll to top Scroll to top