“Kellerman Consulting acted as being a trainer for our new QC employ, so we benefited from that plus the thriving preparing with the SQF audit. We got a ninety eight% within the audit. That should discuss for by itself.
Our staff is composed of a various array of sector veterans and professionals in providing realistic tips in complying with restrictions in the course of your job lifecycle. Amongst our specialists, we’re happy to get several previous GMP inspectors and industry experts who convey on the table their intimate familiarity While using the nuances and intricacies of GMP compliance throughout a venture lifecycle.
We assistance A large number of corporations, like seventeen of the top 25 world-wide pharmaceutical, biotech, and clinical gadget providers, join Using the experts they need to have with the ideal workforce design.
The founding associates, whose unique biodata are supplied on the web site separately, have a solid dedication to Integrity, High-quality and Excellence and function with their clients to accomplish the customer’s targets with entire compliance and demanding adherence to the best moral specifications within a time bound fashion. We Reside upto our stated motto "Knowledge, Abilities, EXCELLENCE" in all our consulting engagements.
Qualification of premises, amenities and products together with the planning with the corresponding documentation
Normal Running Strategies (SOPs) together with all supplementary top quality administration documents (QMS) ought to be optimally tailor-made to each other and also to the corporate's Firm to permit economical and faultless operate in accordance with the respective procedures.
Picking a GMP advisor is usually a significant choice that can form your compliance journey and affect the overall achievement of your small business.
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Kellerman Consulting has supported countless clientele nationwide to properly pass their regulatory inspections as well as their GMP and cGMP certification audits.
I couldn’t have requested for a far better organization to aid us Focus on our certification. They had been practical, instructional, and bought our plan effectively transformed with obvious professionalism.
Inside the pharmaceutical and clinical machine market the Scope of labor (SOW) will vary. here Some consultants want making use of a vague SOW with not A great deal element, which could give them some latitude With all the perform anticipations.Having said that, website this may also become a clue for their insufficient experience. Unfortunately, imprecise SOWs can cause disappointed purchasers that expected sure deliverables at the conclusion of the challenge. An in depth SOW is a good signal you are using the services of a qualified FDA cGMP marketing consultant. A good SOW must have a start out day and an stop day (or not less than an excellent estimated finish date). Some customers signal SOWs with the belief the FDA GMP consultants will get started on their project instantly or not take as long to finish the project.
Combining hugely qualified experts and carefully refined processes with our environment-course engineering.
- 360 diploma audit approach To guage the capabilities and quality programs of suppliers and out-sourcing partners
An important prerequisite for your effective and realistic software of the standard assurance tools is the deep awareness about alternatives and variation.