Training

QC2 offers the following training services:

GCP Training

GCP training for sponsors CROs, vendors, investigators, study coordinators, and site staff.  Training is customized for designated departments, vendor services, and types of studies supported, and focuses on application and interpretation of regulatory requirements.  Training also highlights any recent updates to US, EMA, and/or ICH regulations and guidelines.  Lessons learned from the numerous audits QC2 has conducted are presented, and training specifically related to findings from audits conducted on behalf of the trainee may also be incorporated into course material.

GLP Training

General GLP training for understanding 21 CFR Part 58 requirements and their application.

21 CFR Part 11 Training

Training in 21 CFR Part 11 and EU Annex 11 requirements as well as associated guidance documents.  Training includes application of 21 CFR Part 11 with respect to computer system infrastructure and system development life cycle documentation, as well as human factors related to compliance.  Risk based approaches to validation requirements according to the nature of the software are also covered, including requirements for proprietary versus commercial-off-the-shelf software.

SOP Training

Sponsor, CRO, vendor, and investigator site SOP training to ensure understanding of written procedures and regulatory requirements.

QA Training

Quality Assurance training on audit and regulatory inspection preparedness, audit and/or inspection conduct, as well as responding to FDA or regulatory authority inspection observations.

QC2 training sessions and workshops are customized with your specific needs and convenience in mind.  Training sessions and workshops are conducted by QC2 consultants on-site.  We can accommodate any group size ranging from one-on-one or small group training to large group presentations.  We can also assist with determining specific content and learning objectives.  The training content can range from introductory, generalized concepts to more advanced or highly specialized information.