Compliance / Training

Compliance

QA compliance activities include a wide variety of audits across multiple scientific disciplines. In addition, QPS facilities, equipment, computerized data collection systems and vendors are regularly audited for compliance. QPS SOPs comply with relevant regulatory expectations set forth by the FDA for Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). SOPs also incorporate procedures to support OECD Principles and Japanese MHLW requirements for Good Laboratory Practice.

In general, QPS is continually being qualified, audited and monitored by new and existing clients for compliance, data integrity and overall performance. Quality Assurance senior staff and the departments’ management work together to mutually host a multitude of client and third party consultants throughout each year for qualification audits and technical visits.

Education and Training

Upon hire, all scientists, clinical operations personnel and their support staff are provided a course in Introduction to GLPs and/or GCPs. Each department provides its own new hire qualifications, which consist of SOP reviews; observation and hands-on laboratory training and/or clinical operation training; classroom training and competency testing or investigator approval. Once personnel have mastered a technique or operation, they are deemed qualified to perform that particular function or task independently. The employee’s competency testing or investigator approval is documented in their employee training records and, thereafter, their supervisor monitors their activities and progress. In addition to supervisor support, QPS also offers employees other types of internal and external educational support programs, including scientific seminars, professional memberships and meetings, conferences, compliance programs, quality feedback and technical courses.