Lean GMP for Pharma “Be the Best and Save Big” CPDS has developed a coherent system of methods, trainings and services for complex Pharma lean GMP systems (e.g. ISO 13485 + EU/US GMP).
We can help you with all medical device documentation, e.g. identifying potential compliance gaps early, CPDS helps you proactively manage risks, reducing the likelihood of regulatory issues.
Before you consider whether the CPDS approach is compatible with all your process support software, we strongly support any of your significant existing implementations. Read more
Implementing a process approach is essential for an effective lean Quality Management System. This means viewing every operation within the company as a process. Read more in our brochure.
Do you expect inspection from FDA, EMA, MHRA and PIC/S? Be prepared and make it a positive experience! Read our essential experiences and guidance. Contact us if needed as soon as possible.
Our training program is meticulously structured and thorough, ensuring precision and clarity at every step. Combined with the gap assessment, the best available.
The Neuroscience facts to making your QMS Lean. Please read and find the evidence that word based sop’s combined with “read and understood” training, are not effective. Review the CPDS process model.
GAP analysis is the basic tool on the road to compliance. If performed correctly, it is the foundation for remediation work, and auditing. Performed on all requirements, and controlled.
A Holistic, pragmatic approach for application of Risk Management system (s). Learn in one day different methods and systems and there best place in your product lifecycle. Onsite, with possible exam.
This item addresses resource management (ISO 13485 § 6), and purchasing controls (ISO 13485 § 7.4).
This item addresses Vigilance and Handling communication with competent authorities (ISO 13485:2016 §8.2.3) and Post market surveillance (ISO 13485:2016 §8.2.1)
This item addresses Measurement, Analysis and Improvement (ISO 13485 §8.5) and requirements for associated statistical analysis (ISO 13485:2016 §7.3.6, §7.3.7, §7.5.6, §8.1 and §8.4)