Specializing in Good Manufacturing Practices (GMP) for the Medicinal and Adult-Use Cannabis Industry.
Through Quality and Validation Associates (QVA) I bring 25 years’ experience implementing quality management systems. My experience enables me to provide a streamlined and pragmatic approach to help my cannabis clients establish and maintain quality and compliance excellence.
Who is Quality & Validation Associates?
I, Karl Nusch, am the Principal Consultant at Quality and Validation Associates (QVA). I provide a full range of quality assurance and validation services to help clients achieve compliance with state mandated regulations for the manufacture of medicinal and adult-use cannabis products. Based on over 25 years of establishing and auditing quality management systems (QMS), my skills and expertise can assist your company as it strives to meet its regulatory responsibilities and quality objectives.
As my client, I will actively work with you to identify, establish and maintain a robust and documented quality system that complies with the current GMP regulations for the manufacture of cannabis products. I offer a wide range of GMP consulting services including:
- Assessment of your current QMS to identify any gaps between the state mandated GMP requirements and the practices and processes your company is currently using;
- Design and implementation of a quality system specific to your cannabis manufacturing needs and product types;
- On-site employee GMP training;
- Help with drafting and executing protocols for validation of cannabis manufacturing processes and associated equipment; and
- Audit critical suppliers to ensure compliance with your quality requirements as well as the GMP regulations.
Karl is one of the best consultants that I have ever worked with. When asked which of three of the attributes that best describe him I have a hard time picking just three since he meets or exceeds all of the criteria. His knowledge of the field and the participants is exceptional. He is always available for consultation. The results of his efforts make him the best value that I have encountered.
Karl has an amazing aptitude for all that is Quality in the Regulated industries. He can write equipment validations from scratch (new water system? He can help!). He can write analytical method validations from scratch as well. He knows the ins and outs of all Quality Systems and is a technical genius. Finding a person who is this intelligent across the board is rare. But in addition to this, he is on time, every time AND he possess immense integrity. Finally, he is extremely personable, he’s well-traveled and cultured and an interesting person to know. He is the first person I think to recommend to anyone who needs input, advice or an overhaul of their quality systems.