INSPECTION-READY has been providing support and consulting services since 2007 with core competencies in GxP, ISO 9001, and ISO 13485 compliance, data integrity and quality systems. Our clients include R&D labs, manufacturers and distributors of medicinal products, IMPs, medical devices, diagnostics, APIs and biotech products as well as customers from the energy industry.
As an independent partner, INSPECTION-READY helps companies meet the increasingly restrictive regulatory requirements of national and international authorities in an effective and resource-efficient manner in order to minimize business risks and fulfill authorities‘ expectations.
Even in the case of complex tasks, INSPECTION-READY offers well-structured solutions that often make a significant contribution to process reliability.
INSPECTION-READY Consulting specializes in providing assistance and services in the GxP and ISO environment, with emphasis on:
- Providing GMP, GDP, GLP, ATMP, AMP, IMP, ISO 13485, and ISO 9001 know-how
- Delivering compliance expertise
- Assisting clients by providing expertise, support and onsite training courses covering the implementation and optimization of quality systems according to FDA, EU GMP/GDP, PIC/S , WHO, ISO 13485, and 21CFR820 requirements
- Interim management
- Assisting clients by providing expertise, and support in preparation for and during authority inspections, third-party audits and certification audits by notified bodies.
- Supplier quality assessments and auditing
After more than 20 years in various leading positions in the pharmaceutical and biotech industry as well as in consulting, Gabriela can provide extensive experience and expertise in the pharmaceutical and biotechnology sectors.
She began her professional career at Nycomed AG, now Takeda (Linz), as Head of Microbiology, Head of the Biochemical Test Laboratory and Head of Animal Testing in the area of quality control.
After working at Nycomed, she held various positions as Quality Management Representative for Medical Devices and In Vitro Diagnostics and as Quality Manager for European Blood Plasma Centers, as Global Head of Quality for the GMP / GCP / GLP Divisions, as Head of GxP Compliance & Quality Assurance, as the responsible person for GDP, as Head of External Manufacturing, as Head of Quality Control, as Inspector and as Qualified Person at Immuno AG / Baxter BioScience AG / Shire (Vienna), Baxter Inc. (USA), igeneon AG (Vienna), Aphton Corp. (USA), Whitehall Export GmbH / Pfizer GmbH (Vienna), and AFFiRiS AG (Vienna).
She has many years of practical experience in the planning, development and implementation of quality systems and in quality risk management and has been an auditor for more than 20 years.
Since 2007, she has also been working in the field of training and as a conference speaker on ISO 13485, GxP, and specific issues of relevance to the Qualified Person. Since 2012 she has been working for Concept Heidelberg.
Gabriela has been working as a Qualified Person in Austria and Germany for more than 15 years.
She is a founding member and deputy chairwoman of the Austrian Qualified Person Association (www.austria-qp.at), the interest group for Qualified Persons in Austria (founded in February 2008).
Gabriela Schallmeiner, MSc
Pharmaceutical manufacturers and manufacturers of active ingredients, excipients, primary and secondary packaging, as well as distribution service providers (experience with audits in USA and Asia).
Medical devices and IVD according to EN ISO 13485 and 21CFR820; clinical investigational manufacturers, GLP/GDP, and ISO 9001 audits.
- Audit and inspection support:
Advice and support for preparatory activities as well as optimization measures for upcoming audits or authority inspections (AGES, EU, FDA, WHO, etc.).
Training and monitoring of authority inspections, including FDA, especially in the field of sterile and aseptically filled pharmaceuticals.
Providing assistance when answering letters of complaints requested by the competent authority after authority inspections.
- GAP analysis to determine current GMP compliance status:
A meaningful report is produced as a result of the analysis. If requested, a detailed action plan will be drawn up for each CAP.
- Assistance on planning projects:
GxP-relevant issues should be considered at an early stage of planning through pre-consultation or GxP compliance measures (such as risk analysis or design reviews).
- GxP optimization:
On the basis of up-to-date regulations, standards and guidelines, action plans and concepts are prepared which include an estimate of the required resource and time inputs.
Risk management & risk-based GxP interpretation.
- Implementation and optimization of quality systems:
Conception and implementation of a suitable quality management system.
- Existing systems are analyzed and concepts for optimization, including a catalog of measures, are developed.
- On-site training courses on specific GxP topics:
- GxP documentation:
Conception and implementation of a GxP-compliant documentation system
Design and implementation of a quality management manual, site master file, validation master plan, SOPs, and test specifications
- Quality management:
Development and implementation of quality management system according to GDP / GLP / ISO 9001 / EN ISO 13485.
Assistance during the implementation of GMP quality systems according to ICH Q10, EU GMP, FDA, or WHO guidelines. Conception and execution of internal quality audits
Conception and implementation of supplier quality assessment and auditing systems, including audit execution – also for non-European areas (for example for GMP, GDP, GLP or ISO 9001)
Design and implementation of an effective communication system between relevant departments (marketing, development, quality control) and external bodies (partner companies, experts, authorities).
Assistance on the conception and implementation of an effective training system.
Assistance related to regulatory support for quality issues.
- GMP meets GCP – investigational medicinal products:
Design and implementation of a documentation system in the GCP/GMP area
Assistance with the design and implementation of investigational medicinal product dossiers (IMPD) and product specification file (PSF) documentation.
Assistance related to outsourcing processes such as (biotechnological) manufacturing, packaging, warehouse management, and shipping.
Assistance on regulatory GMP aspects of clinical trials (providing assistance answering letters of complaints and/or additional requests from authorities for study admission).
Conducting supplier audits.
- Batch release review and documentation management
- Deviation / complaint handling, OOS & CAPA
- GxP supplier qualifications and assessments
Interim system support
Organizational changes, combined with personnel changes, are a critical phase for sensitive areas of a company. With an ad-interim mandate, you can directly source competence, experience and knowledge. In order not to have to make a hasty decision on personnel, you can benefit from my competence and experience in the following areas:
- Head of Quality Assurance, Head of Quality Management, quality assurance expert
- Head of Quality Control
- Qualified Person in Austria according to §7 AMBO, in Germany according to §15(3a) & §15(3) of AMG (German Drug Law)
- Quality Management Representative of Medical Devices and IVD
- Responsible Person in Austria according §10 AMBO and 2.2. of EU GDP Guideline
- Project Manager
NETWORK & PARTNERS
- Dr. Bach AG (CH)
- Bernd Renger Consulting (GER)
- Caesaro Med GmbH (AUT)
- Denothex GmbH (AUT)
- Matthias Brunner, PhD – Drug Regulatory Affairs Consultant (GER)
- Norbert Eller, PhD – Clinical Research and Development (AUT)
- Frank Butschbacher Investor Relations & Communications (AUT)
- Oliver Szolar, PhD – CEO Savira pharmaceuticals GmbH (AUT)
- PQMC – Pharma Quality Management Consulting (AUT)
- QBDC GmBH (CH)
- REDL Life Science Patent Attorneys (AUT)
- Sandra Ruch – Project Engineer Life Sciences (GER)
- Uwe von Ahsen, PhD – Austrian Scientific Fund FWF (AUT)
- WISSIT strategische Kommunikationsbegleitung (AUT)
- Wolfgang Viehmann, PhD – InterimManagment & Consulting (GER)