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Homepage > training offer > Closed training > Risk Management in Pharmaceutical Wholesalers
Risk Management in Pharmaceutical Wholesalers

Risk Management in Pharmaceutical Wholesalers

During the training, including workshop elements, participants will learn the principles of risk management and risk assessment in processes carried out in a pharmaceutical wholesaler. We will discuss step by step how to use FMEA analysis – from scoring, through the stages of the analysis, to risk estimation. Together, we will review the analyses being conducted and indicate opportunities for improvement so that they become real support for making operational decisions and preventing undesirable events.

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Open training

Join a group of participants from different companies and discover industry best practices.

Currently no scheduled dates.

Do you have any questions or are you interested in this topic?

Contact us to discuss the possibility of delivering this topic as an open training.

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IN-COMPANY TRAINING

Order a training tailored to the needs of your organization.

2 days / 16 training hours
Stationary / On-line
The day may be established
Individual pricing
Request a quote

wANT TO LEARN MORE ABOUT THIS TRAINING OR OUR OFFER?

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TRAINING PROGRAM

For in-company training, the proposed program is a preliminary suggestion and can be freely adapted to the individual needs of the company.

The following program is indicative (the division into days is arbitrary) and the trainer adapts the course of the training to the specific characteristics of the group. Individual topics may be discussed at a different time or in a different form than indicated in the plan.

Module 1

FUNDAMENTALS OF RISK MANAGEMENT IN A PHARMACEUTICAL WHOLESALER

Content:

  • The essence of risk management in a pharmaceutical wholesaler
  • Risk management in light of the requirements of the Regulation of the Minister of Health of 13 March 2015 on the requirements of Good Distribution Practice
  • Benefits of implementing risk management
  • Overview of risk management methods and tools, including FMCEA and FTA
  • Fundamentals of FMEA

Exercises:

Training participants will be introduced to the essence of risk management

They will understand its nature and basic principles

They will learn the limitations and advantages of the FMEA method

Module 2

RISK ASSESSMENT BASED ON THE FMEA METHOD

Content:

  • The essence of Process FMEA
  • Documentation of FMEA analysis
  • Risk assessment: RPN, SOD, risk matrix
  • Creating custom risk assessment tables

Exercises:

Analysis of FMEA results

Risk calculation using RPN, SOD, and the risk matrix

Defining nonconformities

Defining process characteristics

Module 1

DETAILS OF PROCESS RISK ANALYSIS (PFMEA)

Content:

  • Principles of working with PFMEA
  • Defining nonconformities
  • Searching for causes
  • Determining the effects of nonconformities for three groups of customers

Exercises:

The use of FMEA will be presented using practical examples from the pharmaceutical industry

A short PFMEA analysis will be conducted based on a selected example from a pharmaceutical wholesaler

The principles of risk scoring will be discussed in detail, including defining nonconformities, effects, and causes

The differences between prevention and control from the perspective of FMEA analysis will be discussed

Module 2

FMEA WORKSHOPS FOR A SAMPLE PROCESS CARRIED OUT IN A PHARMACEUTICAL WHOLESALER

Content:

  • Risk analysis for selected processes
  • Evaluation of real examples from pharmaceutical wholesalers
  • Assessment of analyses already conducted
  • Refinement of records regarding control and prevention

Exercises:

Participants will be able to use the knowledge gained during the training to conduct their own risk analyses

FMEA analyses of projects carried out in a healthcare entity will be prepared

ADDITIONAL INFORMATION

After the training, each participant will receive a certificate confirming completion of the training.

WHAT OUR CLIENTS SAY ABOUT US

  • We have been cooperating with PROQUAL continuously since 2016. All projects were characterized by diligent and careful preparation, as well as a flexible approach to our needs. PROQUAL consultants deserve special recognition for their extensive knowledge, training experience, and helpfulness. We wholeheartedly recommend PROQUAL as a proven provider of training and consulting services.
    Sylwia Konsewicz
    Training Specialist – RONAL Polska Sp. z o.o.
  • Training sessions conducted by PROQUAL are characterized by an excellent lecturer–participant relationship. Gaining knowledge during lectures and exercises is an enjoyable experience combined with the expected results. The sessions were organized in a clear and effective manner.
    Jacek Tajchma
    BURY Sp. z o.o.
  • Working with PROQUAL allows me to recommend them as a very reliable and professional provider, knowledgeable and applying modern techniques during training delivery. What sets PROQUAL apart is the quality of services, integrity, reliability, responsiveness, and professionalism
    Kinga Krystek
    Guillin Polska Sp. z o.o.
  • Training on quality management and specific customer requirements delivered by PROQUAL Management Institute met our expectations. The trainers present deep theoretical and practical knowledge, skillfully adapting the content to specific needs, which significantly increases the effectiveness of the training. We recommend PROQUAL Management Institute as a reliable partner in raising quality standards in the automotive industry.
    Marcin Zieliński
    HR Manager – Merit Poland Sp. z o.o.
  • PROQUAL conducted training for us in SPC and PFMEA, which stood out for the trainer's engagement and knowledge. The material was supported by many interesting industry examples, allowing participants to better understand the issues. We can wholeheartedly recommend working with PROQUAL
    Paweł Chodnik
    Manufacturing Engineering Manager – Electrolux Poland Sp. z o.o.
  • The training sessions were conducted very professionally. The topics were tailored to the participants’ level of knowledge and skills, which allowed for proper understanding of the issues. This was reflected in the evaluation surveys completed by participants, where the PROQUAL expert received very high scores.
    Przemysław Zdeb
    Head of Quality Assurance Department
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    phone: +48 71 355 18 08
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    The administrator of the data provided is PROQUAL Management Institute – B.T. Greber Sp.J. with its registered seat at ul. Ostrowskiego 30, 53-238 Wrocław. The data shall be processed in order to respond to your enquiry. For more information on data processing, including your rights, please see our Privacy Policy.