Regulatory Compliance for Pharmaceuticals > Overview

With FDA warning letters and 483s at an all-time high, it is critical that you understand the most up-to-date compliance regulations and how to avoid nonconformances. Partnering with the right firm is key—in this climate, you can’t afford any mistakes.

The Oriel STAT A MATRIX Advantage

Since 1978, Oriel STAT A MATRIX has been helping companies in FDA-regulated industries, including medical device, pharmaceutical, and nutriceutical industries, achieve regulatory compliance throughout the product life cycle. Oriel STAT A MATRIX’s training programs thoroughly teach the regulations. Our consulting programs go an additional step, by helping companies identify gaps in their CGMP programs.

Our experts in performance improvement and regulatory compliance have fully updated our pharmaceutical, biopharmaceutical, biotechnological, and biologics programs to focus on the issues that are highly scrutinized by the FDA and international regulatory bodies. Let us help you establish sustainable changes that address the FDA’s concerns and enhance your overall business quality functions.


Learn More about Pharmaceutical Training and Consulting:
Our standard training courses include those listed below. Click on any course title for more information.
 
Course Name Public On-site
Course Combo: Designing Quality into and Process Validation for Biopharmaceuticals
Course Combo: Understanding Biopharma CGMPs and International Biopharma CGMPs
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

Taken together, these two courses provide comprehensive training on the current regulatory expectations for biopharmaceuticals and an action plan for compliance and implementation.

Taken together, these two courses provide an in-depth overview of the fundamentals of both domestic and international pharmaceutical CGMP regulations. Click to learn more.

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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