Deviation and CAPA Management

4.5 rating based on 35 ratings. 35 students

Deviation and CAPA Management

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

4.5 rating based on 35 ratings. 35 students

GMP & GDP training for pharma & biotech

Language(s):

1 day in total

 922 ex. VAT

Registration ends in 49 days.

The upcoming start date of this training is guaranteed.

What you'll 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

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
Course content

LectureDay
Introduction of the course

1
Review of the eLearning

1
Introduction Deviation Management

1
Describing deviations

1
Impact Assessment

1
Rootcause analysis

1
Human Error Analysis

1
Workshop own deviations Part 1

1
CAPA Management

1
Workshop own deviations Part 2

1
Deviation Management

1
From theory to own practice

1
Quiz & closure

1

Course dates

Start dateEnd dateVenuePriceStatus
04-06-202404-06-2024PCS Training Room 922 ex. VATRegister

Language

  • Dutch spoken language

General information

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

04-06-2024

PCS Training Room

Register

Preparation:
Preparation required:Preparation requirements to be announced
Preparation details:N/A
Exam:
Includes exam:No
Deviation and CAPA Management thumbnail
 922 ex. VAT

Registration ends in 49 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

13 Lectures

Training 5 people or more?

In-house training may be your best choice! We have more than 100 GxP training courses on demand.