FAQ
Frequently Asked Questions
General & Scope
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I work with organizations operating in regulated environments, including pharmaceutical manufacturers, medical device companies, logistics providers (GDP), pharmacies, cannabis-related operations (GACP), and supporting service providers.
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Yes. I support organizations internationally and have experience working across multiple regulatory environments.
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Depending on the scope and objectives, services may be provided on site, remotely, or in a hybrid format.
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Services are typically tailored to the specific regulatory context and scope. Fixed packages may be possible depending on the engagement.
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Yes. I conduct independent third-party audits of suppliers, service providers, and partners, including GMP, GDP, ISO 13485, Data Integrity and GACP audits.
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Audits are concluded with structured, written audit reports that clearly document observations, findings, and regulatory relevance.
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Yes. A draft version of the audit report is first provided to the client for review. One round of factual clarification is included prior to issuing the final report.
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The finalized audit report is issued to both the auditee (if requested by client) and the client.
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Yes. Where applicable, audits include assessment of data integrity principles and controls in line with ALCOA+ expectations.
Consulting & Services
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Where appropriate, consulting activities are supported by written assessments or summaries documenting findings and recommendations.
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Yes. Mock audits and inspection readiness activities are conducted to simulate regulatory inspections and identify potential compliance gaps.
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Yes. Support includes creation, review, and evaluation of GMP documentation such as SOPs, quality manuals, site master files, and validation-related documents.
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Yes. Engagements may include structured project management support for compliance, remediation, and improvement initiatives.
Practical & Administrative
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An initial professional exchange can be requested via the contact options provided on this website.
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Following the initial exchange, scope, objectives, and expectations are clarified to determine an appropriate and transparent engagement approach.
Request Further Information
If you have further questions or would like to discuss a specific topic in more detail, an initial professional exchange is possible.
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Yes. I provide structured GMP training covering fundamentals, advanced topics, inspection preparation, audit behavior, and data integrity.
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Training sessions are available in both English and German.
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Where appropriate, training sessions may be supported by written summaries or reference documentation.
This page provides structured answers to common questions regarding scope, audits, consulting services, training, and practical arrangements. The information is intended to support clarity and expectation management in regulated environments.