THE SHORTEST WAY
FROM ENGINEERING TO QUALIFICATION.

Think. Work. Integrate.

SAVE THE DATE! LOUNGES – CLEANROOM PROCESSES, 17-19/5/2022, KARLSRUHE TRADE SHOW

Ortsschild

The cooperative way – Pitzek GMP Consulting meets gat & H+E Pharma!

17 -19 May 2022
Booth No. G 2.5 | Messe Karlsruhe

Visit us at our joint booth across from Lecture Room 6

Why should you be there?

Because you are also looking forward to a live trade show. Finally seeing others in person.

Because, at our joint booth No. G 2.5shared with our parter gat, or Gesellschaft für Automatisierungstechnik mbH) and that of our guest exhibitor, H+E Pharma GmbH, which is diagonally across from Lecture Room 6, you can get answers to the general questions about our joint approaches that you have always wanted to ask.

Because the two presentations of Pitzek GMP Consulting will give you fascinating insights into “QMS & GMP” and “FDA readiness”.

We are looking forward to an attentive audience.

But that is not all: Are you looking for a contact at the booth who is dedicated to you and your concerns? Following our guiding principle, “project as service”, we would like to offer you a firm appointment for a conversation. To arrange it, please contact our marketer, +49 6321/9 26 26 10 oder silke.fuchs@pitzek-consulting.de.

REGISTER FOR YOUR FREE ONLINE VISIT at expo_lounges_besucherregistrierung with your registration code e6YXXGVD6.

After registering, you will find an option for entering your data and be able view your visitor code and other information about the schedule and the fascinating presentations.

IMPORTANT: Registering as a participant is a condition of your free entry.

 

 

 

Information about the 2022 costs:

For registration by 13 May 2022 (internet only)
• Entry with an invitation day pass: EUR 0
• Entry without an invitation day pass: EUR 15
• Discount entry day pass (official representative, public servant, student): EUR 15

No registration is possible from 14 to 16 May 2022.

For on-site registration 17 to 19 May 2022
• Entry with an invitation day pass: EUR 50
• Entry without an invitation day pass: EUR 100
• Discount entry day pass (official representative, public servant, student): EUR 50

Cancelling or changing an appointment
• by 13 May 2022 – processing fee: EUR 0
• starting on 14 May 2022
– Visitor with an invitation day pass – processing fee/day: EUR 250
– Visitor without an invitation day pass – processing fee/day: EUR 250
– Visitor with discount entry day pass – processing fee/day: EUR 250

We are looking forward to meeting and speaking with you at our Booth Nr. G 2.5

Wir freuen uns jetzt schon auf Sie und sympathische Gespräche an unserem Messestand Nr. G 2.5, diagonally across from Lecture Room 6.

readmore

SAVE THE DATE! PHARMACONGRESS IN DÜSSELDORF/NEUSS, 31/05/ -1/6/2022



Why should you be there?

Because PharmaTechnica and PharmaCongress are returning to their familiar form this year.

Because you will benefit from more than 50 highly professional presentations by GMP inspectors and pharmaceutical companies.

Because you will also meet leading European suppliers for the pharmaceuticals and biopharmaceuticals industries at the familiar PharmaTechnica exhibition.

Because the evening and networking events are fantastic.

Because we are there for you at the PharmaTechnica exhibition.

Because, as co-sponsor, we are looking forward to seeing and speaking with YOU – at Booth No. 24!

readmore

 

SAVE THE DATE! ENGINEERING SUMMIT, 20 -21/7/2022 IN THE DARMSTADTIUM

Why should you be there?

Because the latest questions about best practises, trends, and strategic developments in plant construction will be discussed and, in the areas of life sciences and pharmacy, answered by us.

Because you will benefit from hearing the best speakers and moderators.

Because you will find out what is happening in the industry in these times of crisis.

Because the schedule speaks for itself!

As co-sponsor, we are looking forward to seeing YOU at our booth!

As a participant, you can expect the following focuses:

  • How is European plant construction handling the pandemic?
  • What opportunities are to be had from industry transformation to sustainable management?
  • What role do natural gas, LNG, hydrogen, and Power2X play here?
  • How is digitalisation pushing the industry forward, and how is utility to be had from it?

What methods and processes are promising? How is personnel work changing in the face of competition for talent, and how can remote leadership work?

readmore

New Power at the Head of Pitzek GMP Consulting

Since 1/8/2021, Dirk Leutz (left) has been the new Managing Director of Pitzek GMP Consulting GmbH. He succeeds Dr. Rainer Maué (right), who left the company of his own accord. He is facing new challenges.

We regret to announce the departure of Dr. Maué, who pursued company business with great personal dedication, moving it forward. We would like to thank him for his valuable contributions and wish him all the best for his future endeavours.

At the same time, we are very pleased to announce that Dirk Leutz, who had been serving as Technical Manager/Division Manager Engineering, will be the new Managing Director. We are convinced that Mr Leutz and the Pitzek GMP Consulting team can continue with the successful work of the founder and former Managing Director and refine it.

After his training as a brewer and maltster, Dirk Leutz studied food technology. He began his career at Krones AG. It was there that he first encountered aseptic techniques. After a few stages in his career, he took over as technical and personnel head of a large team and in 2019 joined Pitzek GMP Consulting GmbH as departmental manager in international plant construction in the beverages industry. From the very beginning, he has loved Pitzek GMP Consulting’s corporate philosophy, and he established himself quickly in the company.

“Dirk Leutz is a familiar colleague for us and a familiar point of contact for our customers. We are convinced that his expertise, empathy, and down-to-earth demeanour will enable him to make great contributions to our company’s further growth,” says Thomas Pitzek, founder of Pitzek GMP Consulting GmbH.

Leutz is greatly looking forward to his new duties and intends to continue to press forward with positive corporate development and competent services in the pharmaceuticals industry. He considers systematically orienting on customer utility and fostering customer trust to be especially important. Initially, of course, he will continue to be available to customers in his old function as Technical and Division Manager Engineering.

He describes the challenges facing him as follows: “Every day, we are tasked with finding a balance between meeting the stringent demands of our customers and transacting projects on an equal footing within the planned framework. I am looking forward to working with my team to develop and establish more innovative solutions for our customers and business partners. We want to foster exceptional trust in our customers by offering the best possible service and close, professional support on the part of our GMP experts.”

Pitzek and Leutz are excited about their future together: “Pitzek GMP Consulting has a great deal of potential for developing more specific competences and solutions for our customers in the GMP-regulated environment.”

More Manpower in Sales

A change of perspective – from project engineer to sales manager

Benjamin Peschke was previously employed at Diversey Deutschland GmbH and Co. OHG.

He has several years of experience in various areas of the chemicals, pharmaceuticals, and cosmetics industries and therefore a broad range of expertise. At Pitzek GMP Consulting, he has two more years of experience as a project engineer, some of it at the customer’s premises. His enthusiasm for collaboration with customers and colleagues in projects that are often complex and technically challenging knows no bounds.

Mr Peschke can now pursue his great passion for attractive solutions focused on customer utility in his new position: Sales Manager. He is hugely looking forward to this new challenge. “Most people think that salesmanship is the same as talking. But you have to know that listening is the most important element in my job,” Peschke says.

As someone who used to be active in handball, Peschke knows the importance of performance and teamwork very well. The new Sales Manager is looking forward to fascinating, friendly conversations with customers. “An assumed persona and canned pitches are just not my thing. If I used those techniques, I would not be half as successful as I am with relaxed, open dialogues on an equal footing with the person I am talking to. This will be an exciting time.”

Mr Peschke will pay even more attention to our customers, helping them with questions about GMP and support by our experts.

We are looking forward to his assistance and wish him all the best in his new position.

Would you like to meet Mr Peschke? Don’t hesitate to contact him directly at

Mobil: +49 171 564 76 92
E-Mail: benjamin.peschke@pitzek-consulting.de

OUR COLLEAGUE MAREN KETTNER

Maren Kettner, Projektmanagerin

Unusual hobby
Dog psychologist

“Communication with your dog“

Learn to communicate with your dog properly and analyse its behaviour. It provides lessons for other areas of life.

The magic formula is understanding behaviour and learning to communicate – two important components that are closely related in a consultant’s professional life as well.

Maren Kettner is a customer-oriented, flexible, patient, enthusiastic consultant, and she brings all these strengths to her hobby of being an animal trainer and psychologist. Maren is what you think of when you talk about capable women. She works as a consultant at Pitzek GMP Consulting and trains “problem” dogs and service dogs in her free time.

“Supposed misbehaviour on the part of the dog is often merely the result of miscommunication between the dog and its owner,” Maren says.

This is comparable to problems that occur at work. A dog psychologist provides specific tips and recommendations for improving trust between dog and owner and improving communication for the long term.

Interview with our colleague, Maren Kettner:

How did you decide to become a dog trainer and dog psychologist?
Lots of people have trouble with their dogs. That bothers me as a dog handler. Some “training methods” I have seen contribute to this problem. Besides, I have always had special issues myself, which is how I got into psychology. I like to use my knowledge and abilities to help dogs and people.

You have a companion dog yourself, and that isn’t altogether usual, is it?
That’s right. Fortunately, there are more and more service dogs. Unfortunately, there are also many trainers who capitalize on people’s distress to enrich themselves – and on top of that, they don’t work in a goal-oriented manner…
Bollernose Melwin, my dog, lets me know if my blood sugar is about to tank. This is an important job, even though I have a sensor – it always runs a bit behind real time – so I often don’t notice in time. My dog is always faster and better than technology! A four-legged life-saver.

So what exactly is the difference between a dog trainer and a dog psychologist?
I think that a good dog trainer is also a psychologist, one that serves both members of the human-dog team. My job is not just to teach the dog to sit, lie down, and heel (that is conditioning, which is what a trainer does), but also to assess the entire team and get them to communicate with each other. I have also encountered many dog owners with all sorts of depression.
In one case, I saved a marriage. The couple had been married for 20 years, and the husband moved out because of one of their three dogs. Fortunately, I didn’t know that until my visit was almost over.😉
Then there was a puppy that the vet had given up on after two weeks on drip feed. Fortunately, the family told me what was going on. As soon as I got off work, I went straight to their house. The husband told me about his wife’s depression and what it would mean if the dog didn’t survive. Bello wore a sweater at home because he was so malnourished that he was cold all the time. After a Reiki treatment, he got up, asked for food and water – and wanted to go outside and play. Today, he’s a very healthy dog. That’s all part of what I do. I could go on and on with examples.

In dog psychology, how do you communicate with a dog?
With body language. Many people have trouble reading body language.
And they often don’t even know what they even want.
And they are not clear in their communication. The dog has to guess what is expected of it and decide for itself whether to comply with the body language or the spoken language.

Why are there so many problem dogs? What’s going wrong?
Most of what’s going wrong is in people’s heads.
And unfortunately, lots goes wrong in animal protection services, too. Just the thought that animal protection services neuters or spays all the animals it gets bothers me.
The problems are endless. I could write a book about it.

What makes you an expert in this field?
My years of experience with dogs. I practically grew up with litters of puppies.
My “psychological studies” on people.
My sensitivity and analytical ability.
My adaptation to each situation and each human-dog team.
My scientific background, including in the medical area.
My ability to work energetically.
The interplay of all these factors.

Is there a generic tip you could give to any dog owner?
Lots of them. One of the most important is to let puppies go up and down stairs.

Summary

Sensitivity and patience are the most important virtues here, and they serve our colleague well at work, too. She meets misunderstandings with calm, structure, and clarity.

News about GMP-World

58707739 - grunge gmp (good manufacturing practice) stamp

GMP CLEANROOMS MUST BE QUALIFIED AND CLEANROOM PROCESSES VALIDATED. THIS QUALIFICATION CONSTITUTES DOCUMENTATION THAT CLEANROOMS ARE SUITABLE FOR THE INTENDED PURPOSE

Cleanroom classes according to the GMP Directive, Annex 1 – new 2020 version!

In pharmacy and the aseptic manufacture of pharmaceuticals, classification according to the GMP Directive Annex 1 is usual. It is imperative that the information in the Directive concerning contamination risk monitoring be adequately observed.

Annex 1 of the EU GMP Directive defines limit values for ambient air particle counts and microbiological contamination by microorganisms.

The revised version of Annex 1 was included in the 2020 release of the 12th version. It makes the absolute necessity of a contamination control strategy clear. This Annex contains the general guidelines to be used for manufacturing all products according to the principles of quality risk management in order to prevent any contamination of the end product.

Overall, there are GMP Cleanroom Classes A, B, C, and D. Class A is the cleanest, while Class D allows the maximum permissible particle concentration.

In order to operate a Class A cleanroom, all the cleanroom classes in between must be complied with and may be skipped over under special conditions only. This means that the cleanroom must first move from D to C, then C to B, and only then can A be conceptualised and implemented.

Class A is necessary for such applications as sterile filling. On the way there, each intervening cleanroom class must normally be complied with in turn and may be skipped over under special conditions only. Personnel and material sluices transition between the cleanroom zones.
Room classification according to GMP (Good Manufacturing Practice) is used in pharmacy, biotechnology, medical technology, and the food and cosmetic industries.

Cleanroom qualification and validation involve comprehensive, high-quality qualifications of all cleanroom equipment and systems according to current directives, including comprehensive, gapless, GMP-compliant documentation. Everything should work together perfectly.

We will actively support you in achieving this goal.

A GOOD DEED FOR THE REGION – DONATE AND HELP

In 2019, Pitzek GMP Consulting GmbH laid the foundation stone for a planned long-lasting partnership as a regional promoter of social projects of the Lichtblick day community centre in Neustadt an der Weinstraße. In 2021, it is also supporting Lichtblick with a donation amounting to €1.000,–- for its fight against poverty, social indifference and intolerance.

Robin Rothe, the new dedicated head of the institution, explains the social work of the Lichtblick day community centre to the team of Pitzek GMP Consulting GmbH in detail. “It isn’t easy when such institutions are primarily dependent on donations. From part of the donations, full-time staff, who day after day do more than just espouse our aims, also have to be financed”, says Rothe, head of Lichtblick in Neustadt since 1 September 2020.

The full-time staff as well as volunteers do an enormous amount of work every day and it is difficult for outsiders to imagine just how much they actually do. The signs of the times have been set: the clientele is undergoing a transformation, and this is why Lichtblick is fighting against old-age poverty and homelessness more vigorously than ever before. Every day, more than 50 people needing food come to the soup kitchen, at the moment situated in the Casimirianum; that is a lot. As breakfast is free here, many donations for coffee, milk and sugar are needed.

Nevertheless, Lichtblick does not want to complain; it is glad for every donation and all the more so for generous donations amounting to €1,000.- such as the one from Pitzek GMP Consulting in Neustadt an der Weinstraße.

In 2020, the consulting company for the pharmaceutical, food and biotechnology industries therefore decided that, in 2021, it would not give out any Christmas presents or send New Year’s greetings by post, hopefully aiming to encourage its customers and business partners to make a contribution to the region and make a donation of €1,000- to Lichtblick. “Customer satisfaction and the satisfaction of our employees are very important for us and this is why we are naturally hoping for active affirmation of this campaign”, says Dr. Rainer Maué, CEO of Pitzek GMP Consulting.

The donation cheque was handed over on Tuesday, 2.02.2021, in the new rooms of Pitzek GMP Consulting GmbH, Wallgasse 11, Neustadt, of course in compliance with all hygiene requirements.