Welcome to UBB Consulting
Services
Quality Assurance (QA)
- Quality management systems according to ISO 9001: 2015,
- Technical writing for process instructions,
- CAPA, NCR, compliance handling, field actions,
- function as quality management officer
Remediation Projects
- Function as safety officer for medical devices,
- Food & drug administration,
- Experience with numerous notified bodies,
- Granting of the wholesale license according to AMG 52a
Regulatory Affairs (RA)
- Experience in global / international renovation projects
- Experience in renovation projects for CAPA / NCR / complaint processing
Quality Assurance
- Quality management systems according to ISO 9001: 2015
With a quality management system according to DIN EN ISO 9001: 2015, you can guarantee a comprehensible and transparent process and at the same time send important signals to your customers and partners. Optimize your workflow and increase your competitiveness.
- Technical writing for process instructions
The majority of products sold in Europe follow standards that require extensive documentation. The product documentation includes all documents describing the product. It systematically processes and structures knowledge in such a way that its intent is clearly defined.
- CAPA, NCR, Complainthandling, Field Actions
- Function as quality management officer
The Quality Management Representative (QMB) remains one of the most essential roles in the quality management system. He is the link to all processes and departments and also speaks to managers and executives.
Remediation Projects / Compliance Expert
- Function as safety officer for medical devices
The "Medical Devices Act" stipulates that manufacturers, representatives and importers of medical devices are obliged under §30 to appoint safety directors with appropriate expertise and reliability
- Food & Drug Administration
The FDA's job is to ensure public health in the United States of America. The US Food and Drug Administration is responsible for controlling the safety and effectiveness of medical devices, biological products, and food. FDA laws also apply to products imported into the United States.
- Experience with numerous notified bodies, granting of the wholesale license according to AMG 52a
Regulatory Affairs
- Experience in global / international renovation projects
- Experience in renovation projects for CAPA / NCR / complaints handling
- Technical documentation (according to STED, structure DMR, structure DHF)
- Risk management according to DIN EN ISO 14971
- Assistance in selecting the optimal certifier / review of offers
- Preparation of all employees for audits
- Development files
- Remediation
GMP stands for "good manufacturing practice". This refers to guidelines for quality assurance of production processes and their environment - in the production of pharmaceuticals, active ingredients, cosmetics, food and feed. The GMP requirements are divided into Part 1 and Part 2, together with the corresponding applicable annexes. Quality management systems that are set up in accordance with GMP ensure a product quality that meets the binding requirements of the health authorities and thus enables marketing.
Corresponding guidelines have been drawn up at various levels, for example by the EU Commission, the PIC/S (Pharmaceutical Inspection Co-Operation Scheme), the FDA (US Food & Drug Administration) or internationally by the ICH (Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). In 1962, the FDA first introduced the term "Good Manufacturing Practice" through the current good manufacturing practice initiative.
GDP stands for "good distribution practice of medicinal products for human use" and is intended to prevent counterfeit medicines from entering legal supply chains and to ensure control of the supply chain, thus maintaining the quality and integrity of medicines. The guidelines were put into force by the European Commission on 07.09.2013. The former GSP (Good Storage Practice) is now an integral part of GDP.
Directive 2001/83/EC of the European Parliament with Articles 84 and 85b(3) form the basis of GDP and are reflected in the German guidelines of § 1a Quality Assurance System of the Pharmaceutical Trade Ordinance (AM-HandelsV). Here, reference is made to the fact that the EU guidelines for "Good Distribution Practice of Pharmaceuticals" must also be complied with in Germany.
GxP refers to all guidelines for good working practice, which are particularly important in the healthcare industry. The x in the middle is replaced by an abbreviation for the respective work area. Through our in-depth industry experience, we can help you implement the most important GxP's and enable a fast, smooth implementation that is user-friendly and adapted to your company to save costs and time.
- Translated with www.DeepL.com/Translator (free version)
Further services
- Advice, support and planning for TÜV / FDA audits
- Help for planned and unplanned authority audits
- Project management (with and without personnel responsibility)
- Help in selecting the optimal certifier / review of offers
- Preparing all employees for audits
- Development files
- Remediation
- Planing and setting up supplier audits (external supplier audit)
- Employee training for internal / external audits
- Training of employees on internal / external audits,
- Work on audit findings
- Planning of certification audits
- Help with planning and preparation for the certification of your company
- Help with planning optimal process flows in work and process instructions
- Planning, structure and implementation of QMS according to ISO 9001:2015
References
Customer references
- Well-known companies from the pharmaceutical sector
Lecture references
- Forum - Insitut für Management GmbH
- Concept Heidelberg GmbH
- European Compliance Academy
- German Quality Management Association eV
- Leading Minds Seminars
About me
Uwe Becker
As an experienced consultant in the area of Quality Assurance, Remediation Projects, Regulatory Affairs and Compliance, I have worked very successfully with various companies and many industries, including pharmaceutical companies, freight forwarders and others. Thanks to my large field of activity and my high level of experience, I have already given lectures and training courses at renowned learning institutes and companies.
For several years now I have been working closely with the German Quality Management Association e.V. - GQMA for short - and ECA's GDP Association and I am also a member of these associations.
I regularly take part in further training courses in order to have an overview of the current developments and methods in connection with my work
