Trailblazers at Your Service:
Introducing Our Team of Industry Gurus

Dr. Joachim Ermer

Dr. Ermer, with expertise in pharmaceutical analytics since 1991, held key roles at Hoechst AG and Sanofi, focusing on Quality Control, reference standards, and lifecycle management. He’s a USP Expert Committee member and prolific author in analytical top

Dr. Markus Veit

Prof. Dr. Markus Veit, Managing Director of ALPHA-TOPICS GmbH, is a pharmacist with expertise in pharmaceutical analysis and validation. With 25+ years of experience, he leads training and regulatory affairs in the pharmaceutical industry.

Dr. Stephanie

Dr. Stephanie Pasas-Farmer, a distinguished bioanalytical expert with 20+ years’ experience across global biopharmaceutical firms, CROs, and consulting, founded Ariadne Software® and BioData Solutions®, driving advancements in bioanalysis and regulatory compliance.

James L. Drinkwate

James, an esteemed figure in pharmaceutical compliance, with extensive leadership roles in PHSS, EC-appointed commenting platforms, Annex 1 discussions, and co-leadership in aseptic processing initiatives, currently serving as Head of GMP Compliance at Franz Ziel GmbH

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Upcoming Events

Successful Site Transfers for Manufacture & Quality Control (EU Requirements)

June 25th – 26th 2024

Balancing Innovation, Efficiency, and Safety with Regulations

July 16th – 17th 2024

Crafting ICH Compliant CMC Documents & Maintaining Regulatory Compliance

July 2nd – 3rd 2024

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Let us find your true Potential

We believe that every individual has their untapped true potential hidden within themselves which the right mentor and training could bring to the surface helping to achieve the desired confidence in their field of expertise. We believe research on cognitive and psychology of learning could help us achieve this transformation and align our conferences and masterclasses to support our goal

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Companies Represented By Our Participants

Proud Stories

Michael Durschlag Senior Director QA
Nitto BioPharma, Inc

James provided a comprehensive, detailed, and complete view of Annex 1 updates, tied it to QRM and to PICS guidance. He delivered the material in an easy-to-understand format, and we did not experience any problems with the streaming. The slide material provided will be very useful as a reference.

Nancy Musik Executive Director ,GMP
Shionogi Inc

This was a very in-depth training, and I especially appreciated the real-life examples or possible solutions and real industry examples and mitigation approaches. Trainer definitely a SME on this subject and was able to provide lots of information and background details to explain Annex 1 intentions.

Seth Byers Director, Conjugation Development & Manufacturing
Vaxcyte

Well organized presentation, very knowledgeable presenter, great atmosphere

Vyara Kuneva Specialist Statistician
Sopharma AD

The training offered a large scope of relevant information, presented in an understandable and interesting way. The hands-up approach, supported by examples and simulations makes the content easy to understand and remember. The lecturer was excellent, and the course was very well organized.

Hassan Abdu Al Asmary Chief Human Resources Officer
National Aquaculture Group

Touched my needs, Mr. James is a wonderful lecturer who made it easy and clear.

Gabriela Saucedo Manager Learning Excellence & Quality
Qatar Airways

The facilitator and expert, the documents shared, the excellent facilitation skills of James and being engaged in the session.

Walter Drexler Analytical Services & Support
Takeda Manufacturing Austria Ag

I have never seen such an extensive session on statistics for practitioners on all these burning topics provided. It basically covers all of them we also discuss in our company. A great spectrum of topics covered.

Vassia Papakonstantinou Head of Analytical Development
Demo S.A

I really liked the flow of the presentation, and the way modules were explained using the appropriate ICH references

Nereus Jethro Abad Senior HRBP/Head - OPD
National Aquaculture Group

I enjoyed the class and found it informative, engaging and filled with valuable insights.

Marsha Miller Vice President, Head Of Regulatory
ITB - Med

Pragmatic approaches and clarification on when statistics is useful and when not. Perfect guidance through the official guidances out there and pointing out where they are sometimes contradictory and therefore confusing during application in daily work. Very honorable teacher and very good at making complex things understandable. As the head is spinning after such intense training, the hand-outs and workshop documentation given will help in having the learned content re-called

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Upcoming Event

Successful Site Transfers For Manufacture & Quality Control (EU Requirements)

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Markus Veit

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