Regulatory Compliance for Pharmaceuticals > Training and Consulting

Oriel STAT A MATRIX delivers tailored and practical solutions to guide biopharmaceutical companies in effectively applying and complying with the FDA cGMPs (21 CFR Parts 210, 211), ISO 9001, Process Analytical Technologies (PAT), and the International Conference on Harmonisation (ICH) guidance documents.

Our full-range of FDA Biopharmaceutical consulting and training services will ensure that your company's quality system:

  • Is properly implemented.
  • Provides controls.
  • Produces consistency and quality.
  • Manages and controls risks.
  • Integrates and supports business processes and goals.

In the highly competitive and highly regulated biopharmaceutical marketplace, the need to stay competitive and avoid nonconformances and inefficiencies is greater than ever. 

Oriel STAT A MARIX regularly holds public training classes on biopharmaceutical compliance topics in cities around the United States and in Puerto Rico. In addition, each of our biopharmaceutical compliance courses can be customized and presented at a location of your choice. For groups of five or more, on-site classes are a cost-effective, flexible, confidential way to train your employees in biopharmaceutical compliance. You can trust our highly-skilled trainers to transfer the knowledge to your staff effectively and efficiently.
Our standard training courses include those listed below. Click on any course title for more information.
 
Course Name Public On-site
Designing Quality into Biopharmaceuticals
Investigating and Reporting Biopharmaceutical Nonconformances
Preparing for and Managing Regulatory Inspections
Process Validation for Biopharmaceuticals
Risk Management for Biopharmaceuticals
Understanding Biopharmaceutical CGMPs
Understanding International Biopharmaceutical CGMPs

Companies that embrace Quality by Design (QbD) and a pharmaceutical quality systems approach are in a better position for success. Click to learn  more.

Improper investigation of mix-ups and errors leads to increased regulatory scrutiny and enforcement actions by the FDA. This course provides an understanding of the origin of nonconformances, including human and system errors, and a framework for the implementation of follow-up actions. Click to learn more.

The key to effective management of regulatory inspections is preparation. This program was developed to help participants determine how to build a robust system for handling regulatory inspection and ensuring that all employees follow the process. Click to learn more.

Process validation deficiencies were cited in over 20% of all FDA observations in 2010. This course provides participants with hands-on, practical application experience in planning, conducting, and reporting on process validation activities. Click to learn more.

This course explains principles and provides examples for quality risk management that can be applied to all aspects of pharmaceutical quality. Click to learn more.

Ensure that your organization is fully compliant with the regulations and avoid costly regulatory enforcement actions.

This course will help you harmonize your approach to managing your quality systems and aid you with ensuring multijurisdictional compliance.Click to learn more.

 

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