Public-registration training

Deviation and CAPA Management

4.5 rating based on 35 ratings 4.5 rating based on 35 ratings.
One-day training on deviation management, rootcause analysis, impact assessment and CAPAs

This training includes:

Upcoming edition starts 07-06-2023

Deviation and CAPA Management

One-day training on deviation management, rootcause analysis, impact assessment and CAPAs

4.5 rating based on 35 ratings 4.5 rating based on 35 ratings.

1 day in total
35 students
Upcoming edition starts 07-06-2023

Deviation and CAPA Management

What you will learn

Deviations are really solved by proper research and the use of the right CAPAs

Elevated compliance level

Effective use of resources and less frustration

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Training language(s)

  • Dutch spoken language

Training description

The training

One-day training on Deviation Management, including Root-Cause Analysis, Impact Assessment and Corrective and Preventive Actions (CAPAs).

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.

A practical training in which examples and tools are given to implement yourself in practice.

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

Follow the basic theory about Deviations and CAPAs online in advance at a location and time of your choice (1 hour), followed by a one-day on-site training.
  1. Process of Deviation Management
  2. Impact assessment (impact assessment)
  3. Root cause investigation
  4. CAPA Process
  5. Establish Corrective and Preventive Actions (CAPA)
  6. Example Procedures and Forms
  7. Monitoring timelines
  8. Training your own organization
  9. Workshops – learning by doing

Training program

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.

Program - eLearning Component
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
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

    Training date(s)

    Start dateEnd dateVenuePriceStatus
    07-06-202307-06-2023PCS Training Room 922 ex. VATOpen for registration
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    Lecturer(s)

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    General information

    Learning form:Classroom
    Times:The course starts at 9:30 am and ends at 5:00 pm
    Venue(s):
    Start dateVenueRegister

    07-06-2023

    PCS Training Room

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    Preparation:
    Preparation required:Preparation requirements to be announced
    Preparation details:N/A
    Exam:
    Includes exam:No

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