Effective Quality Management

Qfective provides consultancy services within the field of Clinical Quality Management. Our strategy is risk-based and balanced, which will result in effective quality management.

“Effective quality management requires a balanced approach and a buy-in from all team members.” – Qfective

QA professional

Joke van Wageningen

Joke van Wageningen is the owner and principal consultant of Qfective. Joke is an experienced QA professional who started her career in Clinical Quality Assurance in 2005 at a Phase I unit. Since then she has developed her auditing and quality management skills at various CROs and biotech, working with large, medium-sized and small pharmaceutical and biotech companies, and (academic) hospitals, in roles varying from Clinical Auditor to Directory Quality Management and with various investigational products such as vaccines and Advanced Therapy Medicinal Products (ATMPs).

With a demonstrated history of over 18 years working in Clinical Quality Management roles, Joke’s experience translates into a practical approach. She is a team player, who strongly believes in doing it right the first time, and engaging all stakeholders to assist the adoption of good quality practices as a second nature.

A Curriculum Vitae is available upon request.

How may I help you?

Services

Auditing

From setting up a risk-based audit program, to performing audits and reporting on Corrective and Preventive Actions (CAPAs), we can deliver. The types of audits we offer are Good Clinical Practice (GCP) or Good Clinical Laboratory Practice (GCLP) based and include:

Investigator site audits
Process audits
Systems audits
Subcontractor (vendor) audits
Clinical trial or clinical study audits
For-cause audits.

Audits can be performed on site, or remotely – this depends on the audit topic.

Oversight

If you have to subcontract (critical) aspects of your clinical trial to other parties, keeping good oversight is important. Qfective can help you set up risk-based systems and procedures for your oversight, ensuring your time and effort spent is targeted at the areas of risk to your clinical trial and company.

Standard Operating Procedure (SOP) writing

SOP writing is often an underestimated skill. It takes practice to write an effective SOP, that is compliant with rules and regulations, but also practical enough to ensure compliance. Qfective can help you write the best SOP for your company or clinical trial process, including the development of Work Instructions (WIs) and templates. We believe that SOPs should be written in understandable language, with to-the-point instructions and clearly assigned roles and responsibilities.

“The recipe to an effective SOP is a base of rules and regulations, topped with a generous amount of practicality and a dash of common sense. Served proportionally, of course.” – Qfective

Regulatory Inspections: from preparedness to hosting

From a “do it right the first time” perspective, a clinical stage company should always be prepared to be inspected at any time. Inspection preparedness requires a set of procedures to be followed and training to be taken from the start of your clinical trial and ongoing, which will allow you to be inspection-ready. When the inspection is announced, Qfective can help you organise and host the inspection, including follow-up and CAPA management.

Issue/ Serious Breach Analysis

When it comes to handling significant or complex issues, for example persistent noncompliance or serious breaches, a thorough approach is recommended. Very often, the cause of an issue is much more complex than a simple “lack of training” or “lack of knowledge”. Without a good root cause analysis, the solution may not be found, and the issue will return. Qfective can help you get to the root cause of the issue, and help you come to a lasting and effective solution, meanwhile helping you with the correct documentation.

Gap Analysis

Qfective can perform a gap analysis of your procedures – as a whole or per procedure- to ensure your quality system is complete and compliant with currently applicable rules and regulations, for example when regulations change. Qfective offers a second pair of eyes to identify any gaps, and consultancy on the solution and priorities.

Effective

adjective

producing the result that is wanted or intended; producing a successful result

Quality (Line) Management / Mentoring

Leading a QA department can be a challenge. As the head of an independent department, you need to find the balance between engaging multiple stakeholders (operational teams, MTs, internal or external clients), while maintaining your independence and being able to quickly deal with issues that require (sometimes unpopular) decisions. With many years of experience, we have the skillset to help you with your (interim) quality management. In addition, we offer customized training and mentoring of quality professionals, from beginning auditors to quality leaders.

Training

Qfective can provide various trainings, such as:

ICH-Good Clinical Practice (GCP) (refresher) training
EU Clinical Trials Regulation 536/2014 training
Inspection Readiness training
Good Documentation Practices (GDocP) training
Serious Breach training

Not sure which training is applicable? We can help you assess your training needs and develop a training program.

Effective Quality Management

QA professional

Joke van Wageningen

How may I help you?

Auditing

Oversight

SOP writing

Regulatory Inspections

Issue / Serious Breach Analysis

Gap Analysis

Quality Management

Training

Services

Auditing

Oversight

Standard Operating Procedure (SOP) writing

Regulatory Inspections: from preparedness to hosting

Issue/ Serious Breach Analysis

Gap Analysis

Effective

Quality (Line) Management / Mentoring

Training

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