Deviation and CAPA Management

4.5 rating based on 35 ratings. 35 students

Deviation and CAPA Management

Eéndaagse training over deviatiemanagement, root-cause analyse, impactbepaling en CAPA's

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 is closed.

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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

Program - Day 1
LectureDay
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

Course dates

Start dateEnd dateVenuePriceStatus
07-06-202307-06-2023PCS Training Room€ 922 ex. VATRegistration closed

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

07-06-2023

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 is closed.

Register Now

This training includes:

Training certificate

Lunch buffet

10 Lectures

Training 5 people or more?

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