Public-registration training
Deviation and CAPA Management
One-day training on deviation management, rootcause analysis, impact assessment and CAPAs
Deviation and CAPA Management
Deviations are really solved by proper research and the use of the right CAPAs
Elevated compliance level
Effective use of resources and less frustration
Dutch spoken language
The training
Despite all the preparations, unforeseen problems sometimes arise. In the pharmaceutical industry, you are expected to investigate why mistakes happen and how they can be prevented in the future.
Good research is not easy. Often a root-cause analysis is time-consuming and it is a challenge to get to the real root cause. Common challenges with this are: what are good corrective and preventive actions? How do I make sure nothing is overlooked? How do I monitor timelines? These are just a few examples of the challenges encountered in daily practice when performing deviation management.
Deviation management contributes to improving quality but causes unnecessary loss of time and frustration for many companies. It doesn’t have to be that way!
In this training, you will learn what the expectations are from the GMP/GDP regarding Deviations and CAPA management. The preparation of clear workflows is also discussed, but also how good impact assessments and root-cause investigations can be carried out.
Determining effective corrective and preventive actions (CAPAs) with realistic timelines and preventing exceedances of these timelines is also discussed in detail.
Target group
This training is intended for employees in the pharmaceutical industry involved in the preparation and management of Deviations and CAPAs, such as: QA Managers, QP, RP, QA Officers, Department Heads, Supervisors, and designated employees.
Learning objectives
- Apply and document effective Deviation and CAPA management
- Conduct Impact Assessments
- Investigating root cause to arrive at the right corrective and preventive actions
- Training your own organization with the resources provided, so that the quality of the deviation investigation is increased throughout the organization
Results
- Effective use of resources and less frustration
- Deviations are really resolved through proper research and the use of the right CAPAs
- Increased compliance level
Content
- Process of Deviation Management
- Impact assessment (impact assessment)
- Root cause investigation
- CAPA Process
- Establish Corrective and Preventive Actions (CAPA)
- Example Procedures and Forms
- Monitoring timelines
- Training your own organization
- Workshops – learning by doing
10 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.
| Lecture | Sub-lectures |
|---|
| Lecture | Sub-lectures | Day |
|---|---|---|
| eLearning Deviation and CAPA Mangement | 1 | |
| Deviation management | What is a deviation? Process deviations Drafting uniform descriptions Short workshop: compile deviations | 1 |
| Impact Assessment | Classification of deviation Short workshop impact assessment | 1 |
| Rootcause analysis | Perform rootcause analysis (presentation) Perform rootcause analysis (workshop) | 1 |
| Human Error Reduction | Human Error Reduction (presentation) Human Error Reduction (workshop) | 1 |
| CAPA Management | CAPA Management presentation | 1 |
| Workshop: own deviations | Workshop with deviation from own practice | 1 |
| Training your own organisation | Presentation | 1 |
| Workshop: from theory to practice | Workshop - translating the learned to your own practice | 1 |
| Quiz & closure | Quiz in Kahoot Evaluation and closure | 1 |
| Start date | End date | Venue | Price | Status |
|---|---|---|---|---|
| 07-06-2023 | 07-06-2023 | PCS Training Room | € 922 ex. VAT | Open for registration |
Francis Buiter-Rosenberg
Senior GMP/GDP Trainer & Consultant
Francis Buiter-Rosenberg
To start your registration, first select the start date of the training, then fill in the form below.
Register now!
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| Times: | The course starts at 9:30 am and ends at 5:00 pm | ||||||
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€ 922 ex. VAT
Training certificate
Lunch buffet
10 Lectures
An in-house training is your best choice! We have more than 100 GxP in-house training courses on request.
