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Compliance Regulations and Guidance Affecting your Industry
Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.Categories
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Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
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By - Christopher W. Olmsted
On Demand Access Anytime
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How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime
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FDA Guidance Q9 on Quality Risk Management
- Industry: All FDA Regulated Industry
FDA Guidance Q9 on Quality Risk Management
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In recent years, the importance of quality systems has been recognized in the pharmaceutical industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system.
Draft Guidance: Data Integrity and Compliance with cGMP
- Industry: All FDA Regulated Industry
Draft Guidance: Data Integrity and Compliance with cGMP
US FDA has lately observed increased cGMP violations involving data integrity during inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.
Draft Guidance: Software as a Medical Device (SAMD): Clinical Evaluation
- Industry: Medical Devices
Draft Guidance: Software as a Medical Device (SAMD): Clinical Evaluation
The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.
The guidance states, "Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze, and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD."
Hong Kong Guideline on Anti-Money Laundering
- Industry: Banking and Financial Services
This guideline, issued by the Hong Kong Monetary Authority (HKMA), provides a practical guidance to Financial Institutions (FI) in designing and implementing policies, procedures and controls to meet the relevant AML/CFT statutory and regulatory requirements.
APRA Prudential Standard GPS 230 Reinsurance Management
- Industry: Banking and Financial Services
This Australian Prudential Standard aims at maintaining a specific reinsurance management framework to manage the risks arising from the regulated institution’s reinsurance arrangements. It applies to insurers and Level 2 insurance group. The ultimate responsibility for the reinsurance management framework of a general insurer rests with its Board of directors; and in the case of a Level 2 insurance group, with the Board of directors of its parent entity.
APRA Prudential Standard APS 231 – Outsourcing
- Industry: Banking and Financial Services
This APRA Prudential standard requires regulated institutions to carry out appropriate due diligence and monitoring of their outsourcing arrangements. The standard requires that regulated institutions have a board-approved policy, legally binding agreements and managing processes for outsourcing of material businesses. It also calls for consulting and notifying the APRA before regulated institutions enters into these outsourcing arrangements.
APRA Prudential Standard CPS 232 - Business Continuity Management
- Industry: Banking and Financial Services
This APRA Prudential Standard requires regulated institutions to manage and monitor potential business continuity risks and that the respective boards of these institutions consider business continuity risks as a part of the entire risk management system.
APRA Prudential Standard GPS 310 – Audit and Related Matters
- Industry: Banking and Financial Services
The APRA Prudential Standard GPS 310 requires Authorized Deposit-taking Institutions (ADIs) to provide the Australian Prudential Regulation Authority (APRA) access to independent advice from an auditor on matters relating to ADI operations and internal control processes.
APRA Prudential Standard APS 222 - Associations with Related Entities
- Industry: Banking and Financial Services
This Australian Prudential Standard requires Authorized Deposit-taking Institutions (ADIs) to manage, monitor and control the potential contagion risks which arise due the ADIs being a part of a conglomerate or a corporate group and the dealings between the ADIs and members of these conglomerates or groups.
APRA Prudential Standard GPS 220 Risk Management
- Industry: Banking and Financial Services
This Australian Prudential Standard sets out the requirements for a general insurer and a Level 2 insurance group to maintain a risk management framework and strategy that is appropriate to the nature and scale of its operations.
APRA Prudential Standard 221 Large Exposures
- Industry: Banking and Financial Services
APRA Prudential Standard 221 Large Exposures requires authorized deposit-taking institutions to implement prudent measures and to set prudent limits to monitor and control their large exposures, on both a Level 1 and Level 2 basis. This Prudential Standard applies to all authorized deposit-taking institutions (ADIs) except:
- Purchased payment facility providers (PPF providers)
- Foreign ADIs in Australia that are subject to consolidated supervision by their home country supervisors
Hong Kong Guidelines for Authorization of Virtual Banks
- Industry: Banking and Financial Services
This Guideline sets out the principles which the Monetary Authority (MA) uses when deciding whether to authorize virtual banks applying to conduct banking business in Hong Kong.
Monetary Authority of Singapore Guidelines on Fit and Proper Persons
- Industry: Banking and Financial Services
These Guidelines set out the fit and proper criteria applicable to all relevant persons associated with carrying out of any activity regulated by the Monetary Authority of Singapore (MAS).
- The objective of this Guideline is to ensure that the relevant person performs the regulated activities efficiently, honestly, fairly and acts in the best interests of its or his stakeholders and customers.
Malaysia Guidelines on Financial Reporting for Insurers
- Industry: Banking and Financial Services
These Guidelines address requirements on the application of financial reporting standards and information to be disclosed in the financial statements of insurers. The Guidelines are applicable to all professional insurers licensed under the Insurance Act 1996 (IA).
Malaysia Guidelines on Risk Governance
- Industry: Banking and Financial Services
This policy document on Risk Governance sets out a framework of principles to guide the board and senior management in effectively performing their risk oversight and risk control functions. These guidelines are applicable to all financial institutions. The major objective of these Guidelines is to ensure safe and sound operations of financial institutions.
Malaysia Guidelines on Liquidity Framework
- Industry: Banking and Financial Services
The Liquidity Framework was introduced in 1998 to enhance liquidity management in banking institutions. It replaced the liquid asset ratio requirement. The Framework sets out to:
- Create awareness among banking institutions of their funding structure and their ability to handle short to medium-term liquidity problems
- Adopt a more efficient and on-going liquidity measurement and management for banking institutions
- Provide the Bank Negara Malaysia (BNM) with a better means of assessing the present and future liquidity position of banking institutions.
The Liquidity Framework is applicable to all commercial banks, finance companies and investment banks/merchant banks.
Malaysia Guidelines on Statutory Reserve Requirement
- Industry: Banking and Financial Services
The Statutory Reserve Requirement (SRR) is a monetary policy instrument available to Bank Negara Malaysia (BNM) for purposes of liquidity management. Banking institutions namely commercial banks, merchant/investment banks and Islamic banks should maintain balances in their Statutory Reserve Accounts (SRA) equivalent to a certain proportion of their eligible liabilities (EL), this proportion is called the SRR rate. The SRR is used to withdraw or inject liquidity when the excess or lack of liquidity in the banking system is perceived by the Bank to be large and long-term in nature. This requirement applies to commercial banks, merchant/investment banks and Islamic banks.
Malaysia Guidelines on Credit Transactions and Exposures with Connected Parties for Islamic Ban ....
- Industry: Banking and Financial Services
These Guidelines on the Recognition and Measurement of Profit Sharing Investment Account as Risk Absorbent set out the minimum qualifying requirements for Islamic banking institutions to accord PSIA as a risk absorbent mechanism under the RWCR calculation. This aids Islamic banking institutions to establish sound and prudent policies in the management of assets funded by the PSIA.
Malaysia Guidelines on Data Management and MIS Framework
- Industry: Banking and Financial Services
Bank Negara Malaysia (BNM) has set out these Guidelines on Data Management and Management Information System (MIS) which outline high level guiding principles on sound data management and MIS practices that should be observed by financial institutions.
Malaysia Guidelines on Fit and Proper for Key Responsible Persons
- Industry: Banking and Financial Services
These guidelines implemented by the Bank Negara Malaysia (BNM) define the requirements on the obligations of financial institutions (FI) to assess and determine the fitness and propriety of key responsible persons. The major objective of these guidelines is to ensure that the financial institution is led by persons of integrity, credibility, and competency.
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