Our in-house training courses can be customized to meet your company’s specific needs. We offer customized versions of all of the courses listed here and are happy to discuss topics that may not be currently listed. Our instructors are dynamic subject-matter experts who can help create a customized agenda for your team. 

Areas of expertise include GMP, GCP, GLP, DEA, Clinical Supplies, Medical device, Data Integrity, and more.

Contact us to request more information or to arrange a call with one of our subject matter experts.

Clinical Supplies Training

The management of clinical trial materials is a complex, specialized skillset. Our instructors have extensive experience managing large, international trials.

Data Integrity Training

Data integrity has become a major focus of the FDA over the past few years. Violating data integrity guidelines has led to FDA warning letters, import alerts, and consent decrees.

DEA: Controlled Drug Substances Training

This one day course is designed to help your staff become and/or remain compliant with DEA regulations and to prepare your team for interaction with DEA investigators when they are on-site at your facility.

Dietary Supplement Training

Training is essential for maintaining high standards of quality assurance and compliance to these regulations, and to assure the safety of the supply chain.

Good Clinical Practices (GCP) Training

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, and monitoring, auditing, recording, analyses and reporting of clinical trials.

Good Laboratory Practices (GLP) Training

GLPs: 21 CFR Part 58 refers to a quality system of management controls for analytical and bioanalytical laboratories or animal testing facilities. 

Good Manufacturing Practices (GMP) Training

Good Manufacturing Practices (GMPs) are a cornerstone of pharmaceutical production. Annual GMP training is an FDA expectation whether your company is a large pharmaceutical company or CMO with hands-on manufacturing, or a small, virtual company.

Good Documentation Practices Training

Following good documentation practices, in compliance with FDA regulations, helps ensure control over your processes and is a critical element of Data Integrity. Proper documentation tells what you did, when you did it and how you did it.

Medical Device Training

This program presents the essentials of the device GMPs / Quality System Regulations (QSR, 21 CFR 820), and is designed to promote employee compliance to FDA regulations. 

Preparing for an FDA Inspection

This program will focus on preparing your company for a successful FDA inspection. The course will focus on key GMP and Data Integrity guidelines and can be customized to address on-going data integrity or GMP issues at your facility. 

Regulatory Affairs Training

Regulatory Affairs training can help your team learn about the drug approval process and the differences between CDER and CBER and FDA and EMA regulations.

SOP Training: Developing Effective Standard Operating Procedures

Failure to follow a company’s own procedures is one of the most common observations found during FDA inspections. This program targets personnel that are, or will be, responsible for the development, review and approval, document control, and training of your company’s SOPs.