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Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by James Francum

Guidelines Rules and ComplianceRegulatory bodies like the FDA enact initiatives on a routine basis. While their timing may seem random, such actions are usually driven by logic; most are taken in response to some noteworthy concern. 

Firms that want to respond to sudden regulatory attention may find it advantageous to plan for it in advance. By learning how to implement risk-aware quality management systems, these companies can better equip themselves for success. 

The Purpose and Foundations of Risk Management

Risk management, or quality risk management may incorporate design strategies intended to minimize risks during the routine use of a pharmaceutical, or medical device product. For instance, patient monitoring devices that come into direct contact with patients are generally equipped with electrical safety circuitry, and most drugs incorporate detailed usage instructions. 

In short, the main objective for most risk management actions is to identify potential hazards associated with the manufacture or usage of a device or drug. This also includes risks that could cause deviations from product specifications. 

To fulfill their myriad goals, effective risk management strategies are commonly implemented in response to standardized assessments of hazard. Having identified, analyzed and assessed a given risk or symptom, GxP-regulated entities can more readily quantify risk potential and take appropriate measured actions in response. 

Are FDA Initiatives Predictable?

It's impossible to say with 100 percent certainty what regulators might concentrate on next and there are often “hot topics” that come into play from time-to-time. While these areas can be given additional consideration, it’s important to consider all other requirements and regulations as well to reduce any risk that might jeopardize your product's marketability or your brand.

Risk management strategies should accomplish as much as possible with minimal resources. If your organization can create a flexible risk response protocol, for instance, you'll be able to adapt to new initiatives that place heightened value on specific criteria. 

Initiatives that take the form of rule changes or guidance publications can be hard to decipher due to their complexity and breadth. Effective anticipatory risk management strategies incorporate systems like Corrective and Preventive Actions (CAPAs), Failure Mode and Effects Analysis (FMEA) and other FDA-recognized methodologies so that even if the regulatory specifics change, firms can use consistent methods to establish their compliance.

Demonstrate Your Understanding Through Action

FDA initiatives may not always establish new laws or statutes right away, but in the life science industries one must always pay attention to the events leading to these new laws and statutes. Inspectors are quick to embrace the ideas and concepts found in guidance documents through their fundamental / basic training, and your organization must be equally ready to change. 

The most reliable way to demonstrate your willingness to comply is to prepare your compliance system for action. Identify effective risk management strategies and implement them without waiting for an initiative or guidance to kick you into high gear. 

Proactive organizations find it easier to surmount ever-increasing regulatory challenges. Your company would do well to take the initiative before new laws force you to step into line at a less than optimal cost. Contact GxP-CC consultants soon to open your path to regulatory compliance.

 

 

Posted in Compliance Consultants, FDA & European Regulations, FDA Risk Management Initiatives, GxP CC, Quality Management Systems, Risk Management

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James Francum

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