Portfolio
Quality Management
Nothing is more constant than change.
A quality assurance system with all its processes requires constant change and adaptation to meet the requirements and tasks of the customers, the organisation and the authorities.
I have extensive and comprehensive experience in working with quality assurance systems, especially under GLP and GMP, and will be happy to assist you with all work, such as the:
- Implementation of a quality assurance system
- Implementation of individual elements in an existing quality assurance system
- Evaluation of quality assurance systems or individual elements with regard to compliance with laws and regulations
- Analysing and optimising of processes for effectiveness and efficiency, taking into account regulatory requirements
- Restructuring of systems, e.g., for expansion, harmonisation, or realignment.
Support is available for processes development, project management during implementation and the preparation of standard documents/work instructions/SOPs and their training.
Quality Control
I would be pleased to offer you my extensive experience in quality control combined with my sound training in the field of analytics in the following areas:
- Development and validation of analytical procedures.
- Changes, Deviations/CAPA, Complaints, Out of Specification (OOS)
- Preparation and review of documents
- Equipment qualification, computer validation
- Supplier selection and qualification
- Method transfer
- Quality agreements
- Risk analysis
Analytical method validation
Validation empirically determines the capability of an analytical method. Inadequate validation will lead to incorrect results or insufficiently robust procedures, often for years, as validations are only performed at longer intervals. Validations may seem trivial, but the details are often challenging.
I offer my knowledge and experience for
- Design of method validation according to ICH Q2(R2), also for bioanalytical methods
- Support in the preparation of validation protocols/plans and reports
- Assistance with statistical evaluations
- Support in the determination and evaluation of key figures.
Method transfer
Method transfer requires careful planning and ongoing monitoring. Problems often arise because information has not been or is not being shared. I am happy to share my experience in the preparation and implementation of technology and method transfer.
Changes, Deviations/CAPA, Complaints, Out of Specification (OOS)
The correct and timely handling of changes and the various types of deviations is crucial for a well-functioning quality system as well as for customers and authorities.
I have extensive systemic and practical experience with variations and nonconformities.
I am happy to assist you with:
- Change introduction and implementation
- Handling deviations and CAPAs
- Complaint handling
- Defining acceptance criteria/system suitability criteria and specifications
- Processing of OOS results
Document preparation and review
“What is not documented has not been done…”
Document review is often a bottleneck and the speed determining step. I am happy to help with:
- Preparing/updating, reviewing and approving of test specifications and reports
- Reviewing manufacturing, test, qualification and validation documentation (instructions, records or reports) for accuracy, completeness and compliance
Equipment Qualification, Computer Validation
Qualification of equipment and the validation of computerised systems or Excel sheets are often additional tasks for which there is a lack of resources or knowledge.
I am happy to assist you with
- Qualification of equipment and validation of computerised systems
- Verification of qualification of equipment and validation of computerised systems
- Preparation of the necessary documents for qualification and validation as well as for operation and maintenance
- Preparation and validation of Excel spreadsheets
Supplier selection and qualification
Sufficient due diligence and management of suppliers is important for efficient collaboration. I am happy to contribute my experience in the selection and qualification of suppliers as well as in the drafting of agreements, protocols, and reports.
Quality Agreements
Quality agreements are important to regulate collaboration and are required by GMP. Agreements should be reviewed regularly. The preparation, review and maintenance of quality agreements is time consuming and requires not only legal but also regulatory and systemic knowledge. I would be happy to assist you in drafting and revising quality agreements with my many years of experience from the perspective of a service provider.
Risk Analyses
Risk analysis has not only been important since the publication of ICH Q9. They are the tool to identify critical processes or steps and thus distinguish between the important and the unimportant. In this way, they increase efficiency and save resources. They also reduce the risk to the process or product.
It is important for risk analysis that all relevant skills are involved and that the process is strictly moderated.
I am happy to support you in the preparation and moderation of analyses and risk analyses, e.g. FMEA, HACCP, FTA, brainstorming, mind mapping.
Education and Training
Quality requires qualified personnel. Particularly in the technical-scientific environment, training courses are not carried out with sufficient regard to the learning behaviour and receptiveness of the participants. What is important is not what is said/presented, but what is remembered and implemented by the participants.
I would be happy to conduct training courses in your company that are practical, participant-centred, demand-oriented, didactically prepared and methodologically diverse.
Here are some examples:
- GLP/GMP basics
- Change Control, Deviation Control, CAPA, OOS, Complaints
- Documentation in the GLP/GMP environment
- Qualification of equipment and facilities, validation of computerised systems
- Costumer audits
- Inspections by European and US authorities
- Validation of (bio)analytical methods.
All training is prepared and delivered individually. Exercises and practical application are emphasised. Success controls are carried out on request.
Audits and Inpections
The success of an audit is determined by the content…. No!
The “psychology” of an audit is crucial. Of course, the technical content has to be up to date and compliant, but the way you present yourself, your appearance, your communication, etc. are the key factors that determine the outcome of an audit.
I have extensive experience in the role of auditee and auditor in an international environment, in German and English.
I would be pleased to assist you with:
- Preparation, monitoring and follow-up of customer audits or regulatory inspections
- Training in preparation for audits and inspections
- Carrying out pre-inspections including preparation of action plans
- Mock inspections (English/German)
- Performance of (self)inspections
- Supplier audits according to GLP, GMP, ISO 9001 and 13485.
Project Management
All projects and works require planning, monitoring and control, as well as adjustment when planning is inadequate. I am happy to manage projects in a regulated environment.
In all work and projects where people are involved, there are periods of lower efficiency. Changes are received and implemented differently. I like to add coaching of individuals or small groups to enable change and achieve goals: Doing new things, doing existing things differently, learning from the past.
Interim Activity
Contact me if an activity is temporary, or if positions cannot be filled or re-filled in the desired time.
I am happy to take on interim roles in quality management and quality control.
You will benefit from my many years of experience in the quality management of a service provider for the quality control of pharmaceutical, in particular biopharmaceutical products for international clients.