Basel II Operational risk - best practices

What is Operational Risk ?

The Basel II accord on banking supervision defined operational risk as the risk of loss resulting from inadequate or failed internal processes, people and systems or from external events. Legal risk would be included in this definition according to the Basel committee, but not strategic or reputational risk

Operational Risk Failures

Internal Fraud - Losses due to acts of a type intended to defraud, misappropriate property or  circumvent regulations, the law or company policy, excluding diversity/ discrimination events,
which involves at least one internal party.

External Fraud - Losses due to acts of a type intended to defraud, misappropriate property or circumvent the law, by a third party

Employment Practices and Workplace Safety - Losses due to acts of a type intended to defraud,
misappropriate property or circumvent the law, by a third party.

Clients, Products and Business Practices - Losses arising from an unintentional or negligent failure to
meet a professional obligation to specific clients (including fiduciary and suitability requirements), or from the nature or design of a product.

Damage to Physical Assets - Losses arising from loss or damage to physical assets from natural disaster or other events

Business Disruption and System Failures - Losses arising from disruption of business or system failures

Execution, Delivery and Process Management - Losses from failed transaction processing or process
management, from relations with trade counter parties and vendors


5 Best Practices to Follow in Operational Risk Management

1. Develop, Implement and Maintain a Framework for Operational Risk Management
2. Design the Right Operational Risk Governance Structure
3. Use Right Tools to Identify and Assess All Operational Risks
4. Implement an Approval Process for New Products and Processes that Assesses Operational Risks
5. Maintain a Robust Operational Risk Reporting Mechanism

A detailed Whitepaper on this subject available Here

Manufacturing and Branding Cosmetics – 5 Best Practices to Follow for Regulatory Compliance

1. Determine if product is a cosmetic or drug
2. Ensure cosmetics are not adulterated
3. Brand cosmetics properly
4. Establish a comprehensive product surveillance program
5. Check ingredients are not on the prohibited and restricted list

Read in details for each best practices click here to down load this whitepaper

Information Security Framework A-Z

This whitepaper describes about the information security frameworks, rules, security recommendations and obligations of various kinds.
Audit Checklists and ICQs
Basel II , III, GLBA, FFIEC
BSC
COBIT
Calder Moir IT GOvernance framework
COSO
FISMA
FOIA

an many more

Click here to download this whitepaper

UK bribery act - whitepaper

This whitepaper takes another look at UK bribery act, what it constitutes and the implications it holds for businesses operating in England, Scotland, Wales and Northern Ireland.

For businesses that operate in the UK, conducting exemplary due diligence has now become even more important, so download this white paper

Importing Medical device to US - Best Practices White Paper

The FDA does not recognize regulatory approvals obtained in other countries, therefore foreign firms that manufacture medical devices imported into the United States need to comply with applicable US regulations before doing so.

• Importers should ensure that they comply with the following:
• Establishment is registered with the FDA
• Devices have been listed with the agency
• Devices are manufactured in compliance with FDA's Quality System Regulations or QSR
• Adverse events related to medical devices are reported in a compliant manner
• Premarket Notification (510(k)) or Premarket Approval have been obtained from the FDA for any device to be imported into the US
• Foreign manufacturers should have a designated agent in the US.

In addition to FDA regulations, the importers must also comply with Customs and Border Patrol (CBP) requirements.

To get a detailed account of all regulations and best practices for medical device import download this free whitepaper on medical device import.

Also you can attend the seminar -FDA's Import Requirements and Managing the Import of FDA Regulated Products: 2-day In-person Seminar