Good Manufacturing Practices (GMP) Intro Course for Recruitment Consultants
Public / Private
SESSION TYPES
Virtual Class
Location
Beginner / Intermediate
Skill Level
~8 Hours
Duration
€750
Public Session fee
(PER PERSON)
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Course:
Overview
Do you know the origins of the term GMP? What role plays each employee in the pharmaceutical company? Do you know about the responsibility and accountability of the Qualified Person?
Most recruitment consultants don’t!
The life-science recruitment industry is growing rapidly, and headhunters who don’t have a good understanding of the industry let opportunities slip through their fingers.
After our introduction course, you’ll know what GMP is really about! You will get exposed to what day to day work is at a pharma company.
Join our GMP introduction course, get acquainted with the key players in this lucrative industry, and learn about what they do and how their activities intersect.
Get in touch with us now to arrange a private session at your organization or get information about future public ones.
After completing this course you will:
- Understand why GMP is so vital for our modern life
- Comprehend the complexity of the Pharmaceutical Quality System (PQS)
- Understand the key roles in the pharmaceutical industry
- Get familiar with the main GMP regulations
- Be able to speak with your candidates on eye level
Who is the training for?
The course is highly beneficial for recruitment consultants/headhunters who work within the regulated GMP environment and want to understand and speak the same language as their candidates.
Topics
The topics can be adjusted and customized to your requirements.
Learn about the pharmaceutical market and what make it ticks. We will cover the essence of the pharmaceutical industry and the drug discovery phases.
Learn about how GMP came to be and why it’s so vital for our life.
Learn about the 7-pillars of the Pharmaceutical Quality Systems (QMS)
Learn about the GMP requirements in regards to the qualification of the employees that work in a pharmaceutical environment.
We will talk about the main roles in the pharmaceutical productions and you will understand where each of them fits in the organization and their duties.
- Learn about the requirements and the responsibilities of the Quality Unit.
- Understand the difference between the QA and the QC departments.
Learn about what the regulations expect from the various facilities in pharma. We will discuss the manufacturing floor, the labs, warehouses and auxiliaries.
We will discuss the difference between qualification and validation and their purpose. Then, we will go over all the required documentation and the stages of a successful validation and qualificaiton.
Good documentation practice is vital for GMP. In this section we will cover all the important regulations and you will learn how to document correctly, avoiding the most common pitfalls.
We will also cover 21CFR part 11 and ALCOA.
You will learn about the difference between an audit and an inspection and understand the expectations of the regulators.
We will cover both internal and external audits, and you will learn about all the phases of the audit.
You will be able to ask any question that may help you accomplishing your job better!
About the trainer
Yan Kugel
Yan is a GMP quality expert and the managing director at Qualistery GmbH. Through his vision, the company takes complex GMP topics and transforms them into engaging and enjoyable GMP training videos and training programs that captivate the audience. As a result, GMP professionals retain more information, which they can successfully use in their workplace. This is highly beneficial for the employer as for the career of employees.
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