PGC's experienced auditors are contracted to perform internal and supplier audits for our customers. In addition, we offers “Audit Process Management” services, in which we facilitate all aspects of internal audit programs by creating an effective annual schedule covering all necessary subparts of the regulations and/or standards, scheduling the audits within your company, performing the audits, then providing a detailed report, and a path for corrective actions as a result of the audit findings if required.
“Audit Process Management” also includes facilitating our client's supplier quality management program. You provide us a contact list of suppliers requiring audits and we will handle everything from scheduling of the audits and travel arrangements, to performing the audits and providing a detailed report. We can even facilitate any needed supplier corrective actions at the request of the client.
The end result for our clients is complete audit management at a fraction of the cost of having an on-site staff to manage audit schedules.
A company needs to know which elements of a quality system require attention, in order to know what to correct, in the name of continuous improvement. We perform gap analysis' for our clients and provide a detailed report showing where the deficiencies are so issues can be addressed prior to an FDA or ISO audit.
PGC implements complete quality systems meeting CFR820, 211, ISO13485:13485, and ISO9001:2008 requirements for start-up companies and suppliers to medical device companies. We also re-engineer existing quality systems to assure compliance to regulations/standards while promoting continuous improvements, many times as a result of a PGC gap analysis.
PGC provides investigational and documentation support to its clients for all aspects of corrective actions, whether they are a result of internal audits or nonconformances, or external audits from the FDA, ISO audits, or customers. Our skill and experience will allow for the implementation of corrective action plans which will assure issues will not reoccur.
PGC provides training that is current, relevant, and based on the consultant's real-world industry experience. Current training includes basic cGMP/Standards Training (perfect for new employee orientation or annual refresher training), Advanced cGMP/Standards Training (for manager/supervisory level personnel), Internal Audit Training, Quality Management Training, Process Development and Documentation Training (lean compliance), and CAPA System Training. We will be happy to customize any training presentation to meet the needs of their clients. Our training is quoted on a daily rate, not by the number of employees attending a training session, which is very cost effective for our clients.
PGC also services such as 510(k) submission and CE marking, as well as process validation. Contact us for further details.