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Regulatory Compliance

How to secure GCP compliance in Clinical Trials: – Webinar By ComplianceOnline

Why Should You Attend:

Applying GCP in a real life situation is often subjective, requires experience and training. A Clinical Trial, like any other project is divided in stages with tasks running in parallel or in sequence and affecting one another in a cause and effect relationship. Over the years, findings of inspectors and experiences of monitors have identified clusters of deficiencies in complying with GCP principles, key areas that emanate straight from the GCP guidelines.

This presentation will shed light on what one needs to pay attention to, in order to run a clinical trial in a GCP compliant manner, securing both results and quality. By defining the key parameters and providing lists of common deficiencies, an understanding of how to progress through each stage of a project and what to watch out for will be gained. As a result, working knowledge of GCP will increase.

Areas Covered in the Seminar:  Read more...

Pharmaceutical Compliance Training

Even after the presence of cGMP, the pharmaceutical companies are in need for quality compliance training. The pharmaceutical compliance training equips them on various aspects related to regulatory compliance. It must be known that the compliance solutions tend to vary from one firm to other. In that manner it is not advisable to go with any standardized solutions but opt for specific ones. But it will be beneficial for the firms to consult such consultants who can provide with circumstance based solutions. The other method is that the pharmaceutical companies can put their professionals under the pharmaceutical compliance training program. They can use the specific training to face the compliance challenges. Some of key areas focused under the training program are discussed below.

Document Investigation- Documents form a very important part of the entire compliance process for the pharmaceutical companies. They are often subjected to documenting investigations. They can earn suitable documents that cover all the information. It is vital for the pharmaceutical companies to look after the issue that all the information are collected and presented in proper format.  Read more...

What’s New in Healthcare Regulatory

Did you know that HIPAA 5010 and ICD-10 rulings have impacted close to 80% of most enterprises’ health plans, business processes and systems? The administration has imposed definite deadlines for migration and completion of replacements and HIPAA 5010 involves the adoption of new claims guidelines, eligibility inquiries, payment advice, recommendation or referral authorizations and several other transactions. This migration process espouses a restructured version of the National Council for Prescription Drug Programs (NCPDP) standards and also the Medicaid pharmacy subrogation transaction standards. ICD-10 is the US Department of Health and Human Services (HHS) regulation that is set to replace ICD-9 clinical modification sets. It basically includes the revamping of existing coding systems in all healthcare enterprises. So while the timeline for HIPAA compliance 5010 is Jan 1, 2012, and for ICD-10 it is Oct1, 2013, it actually means that after these deadlines, all electronic claims and services (including medical diagnosis and in-patient procedures) should necessarily use version 5010 and ICD-10 respectively.  Read more...

The Future of Outsource Financial Compliance for Investment Funds

In this day and age of fraud, financial investment compliance is becoming more and more important. Just doing a Google news search of “financial fraud” or “CFTC fraud” brings up hundreds of recently found fraud schemes. There are so many within an one or 2 week time frame. The easiest and most cost conscious way of resolving this issue is through financial investment compliance at a hedge fund. Having independent investment compliance will benefit the RIA in several ways.

One of the most important things to a financial firm is its clients. Clients are the bread-and-butter of the investment firm. Without the client there will be no hedge fund. A trend for clients after the Madoff mess is having a secure and sound investment firm. Clients are also doing more due diligence on their own on a particular fund. Also, clients are now looking to make sure that investment firms are following SEC guidelines before even giving consideration to them. Investor faith is very important for a fund. One of the easiest ways to have investor confidence is to have an independent compliance department. Low cost outsource compliance eliminates many conflicts of interest that can happen within a firm.  Read more...

Email Compliance – Are You Ready for It?

Most business today is conducted by email, including sending important and sometimes confidential messages. According to Osterman Research, email contains approximately 75 percent of the information used by an organization’s individuals on a daily basis. With so much information going around the world every day, many companies often ignore regulatory compliance. Email compliance regulations and laws, such as Sarbanes-Oxley (SOX), Gramm-Leach-Bliley, HIPAA and the Federal Rules of Civil Procedures, have forced organizations to know more about the information stored in their systems than ever before. Email today contains a host of valuable and highly sensitive information that needs to be stored, retrieved and viewed on demand.

Conserving email has been made mandatory, thanks to the various regulatory compliance and legal risk management regulations that govern every country. It is top priority for IT managers today due to regulatory obligations and harsh penalties along with the prospect of enormous civil damages and even criminal prosecution. An email archiving solution is mission-critical to satisfying these obligations. Having regulations policies in place can save your company significant hassle and protect it from the financial implications of non-compliance.  Read more...

How To Choose The Correct Compliance Training Solution?

The world is changing fast and so are the norms for conducting business. Today some industries, mainly the food, pharmaceutical and the service industry has to work under strict regulatory guidelines. Hence, they are required to meet the compliance requirements regularly to stay operative.

Choosing the right compliance training solution however can be time consuming. There are so many applications available in the market nowadays that companies find it difficult to find the best solution to fit their workforce. Also choosing the correct solution has an impact on the entire workforce so it is crucial to select the correct solution.

New advanced Compliance Training solutions have emerged to the marketplace that are both cost effective and helps clients remove the hassles and headaches faced each day by training managers, health & safety managers and the HR team when trying to remain and stay compliant within industry. The following are some tips to help you choose the best solution to fit your organisation.  Read more...

CMO COMPLIANCE Audit, Risk & Compliance Software selected as leader by Forrester Research Inc, an independent research firm

Atlanta / London / Melbourne 10 December 2010 – CMO COMPLIANCE, the world’s leading audit, risk and compliance software solution, announced today that it has been selected as a leader in a report from Forrester Research Inc. titled “Market Overview: GRC Platforms”

CMO COMPLIANCE was officially recognized as being one of the most flexible and configurable Governance, Risk & Compliance solutions across different industries, with it being one of only 2 vendors to have a core focus on Quality and Health & Safety, the other being SAP.

As the leading provider of audit, risk and compliance software solutions, CMO COMPLIANCE has been providing global organisations with solutions for automating the workflow and documentation for the scheduling, performance and reporting of audits or assessments, with other modules available for document management, issue and action tracking, competence management, incident management, dashboards and reporting for applications including corporate governance, vendor assurance, regulatory compliance, health and safety, quality assurance, environmental management, risk management and financial management.  Read more...

Compliance Management Challenges for 2011

Forrester research defines compliance management as “a process of establishing an appropriate set of controls within the IT environment and managing the implementation of those controls”. Going by this definition, it would be appropriate to note that more than half of the enterprises today have un-patched vulnerabilities in their applications (controls) with regulatory compliance still ranking high on their security teams’ agendas. The lookout for an effective and efficient vulnerability and compliance management solution still remains on top of all enterprises’ ‘must do’ lists. Security experts across enterprises are looking for a solution that can provide optimal compliance management without any security lapses.

2011 is the year when enterprises will be facing off on issues related to compliance and regulatory demands. Here is a sneak peek into some issues that could be the focus in 2011 as far as compliance management is concerned:  Read more...

China – Compliance Processes for Life Science Products: – Webinar By ComplianceOnline

Why Should You Attend:

China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.

This 3 hrs course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the SFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.  Read more...

The Electrical Safety Program Book

  • Special aides including assessment checklists, forms, and helpful tables
  • Sample lockout/tagout procedures that readers can modify and use directly
  • Energized work permit that helps management understand the relationship of electrical hazard exposure to the work process
  • Training presentation developed to use with your workers to discuss electrical hazards
  • All forms and checklists from the appendices in electronic format

Product Description
The Electrical Safety Program Book provides the detailed blueprint to help you develop a program that maximizes electrical safety–and the related benefits it generates. Written by experts in the field of electrical safety and based on the 2004 NFPA 70E® and OSHA rules, this manual will help you make safety an integral part of your business. Learn how to convert OSHA regulations into an effective working plan. Arranged in a logical order, this book explores the full range of operational and administrative issues involved in developing an electrical safety program and provides guidance and resources to resolve them. Extensive appendices for each chapter include a wealth of practical and time-saving tools such as checklists, sample budgets, a personal protective equipment matrix, and permits. Now, a free CD-ROM containing the following is also included free with each text
$108.95
The Electrical Safety Program Book

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