Online Safety Community

What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines Agency (EMA), or The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK, or The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or any other around the world.

The regulations these regulatory agencies set are aimed at ensuring compliance with standards. Of course, it goes without saying that these standards are aimed at ensuring quality and safety of drugs and other health-related products such as medical devices, food, medicines, life sciences and pharmaceutical products. It is to be in compliance with the regulations set out by these agencies that organizations that come under these regulatory bodies spend a fortune.

Why? Simple:

- Being in compliance ensures that their products are approved for release into the market, failing which all that they spend on producing the product goes down the drain;

- Lack of compliance results not only in hefty penalties and fines and other punishments which could go all the way to imprisonment; it could also result in earning a bad reputation, the quickest means to get out of business.

Compliance requirements, expectedly, are very stringent. This is very natural, considering the nature of the products that are regulated. No regulatory agency likes to take chances with the health of the people. One spurious drug in a lot of thousands could be enough to cause damage to the consumer. So, regulating these products is as onerous as ensuring the security of every individual in a nation or society.

Compliance requirements are couched in very formal and often incomprehensible language. Since the industries are highly specialized, it is impossible for the regulatory agencies to avoid jargon or legalese. It is to help understand the nuances of these regulations that organizations need the services of compliance professionals. These professionals are specialized in the particular and exact nature of these regulations and do what is required to ensure compliance.

Despite the existence of these compliance officers, many organizations could still need understanding of the regulations. This could sometimes be because of the frequency of the regulatory updates or the urgency in meeting their requirements. Or, these could be beyond the resources the organization can allocate or afford for meeting compliance requirements. Further, the nature of some regulations could be such that even experienced compliance officers may need clarity. On such occasions, organizations need the services of compliance trainings.

Views: 30

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

John Robinson posted a blog post

FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe…See More
1 hour ago
kate smith posted blog posts
2 hours ago
Traininngdotcom-LLC posted blog posts
3 hours ago
Mark Nilson posted events
3 hours ago

Forum

How to provide safety to the small laboratories at schools? 4 Replies

Most schools in villages are opening small chemistry laboratories and allowing the students to experiment whatever they have been taught. The education quality of village schools is not up to the…Continue

Started by charlieelectra. Last reply by Jen McDade 8 hours ago.

Workers paticipation in safety management 1 Reply

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Jen McDade yesterday.

Road Safety

What can be the best measures for Road Safety?Continue

Started by Jen McDade Sep 27.

safety equipments in breweries 4 Replies

safety equipments in breweries -- kindly provide detailsContinue

Started by ajit. Last reply by Jen McDade Sep 24.

Unusual Safety Tips 10 Replies

Please share some unusual but genuine safety precautions.My unusual safety tips - Don't drink sweet fruity juice while driving in the night as it contains sugar and sugar slows down your blood…Continue

Started by Arnold Brame. Last reply by Jen McDade Sep 24.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service