Today we are here talking about community policing – that’s a term that is used a lot and captures much of what the Houston Police Department has done for decades, but is not often explained.

The Department of Justice, the Environmental Protection Agency and the United States Attorney’s Office announced today, the settlement of claims against ConocoPhillips Company and Sasol North America Inc. to resolve their liability to EPA under CERCLA for contamination in the Calcasieu Estuary of Louisiana.

The Justice Department announced today that it will monitor municipal elections on March 8, 2011, in Maricopa County, Ariz.

The Justice Department today reached a settlement agreement with the Maricopa County Community College District in Arizona, resolving allegations that the district engaged in a pattern or practice of discrimination against non-citizens in the hiring and employment-eligibility verification process.

The Justice Department today announced that it has entered in to a court-enforceable agreement with the Maricopa County Sheriff’s Office (MCSO) and Maricopa County Sheriff Joe Arpaio resolving a longstanding dispute over access to information related to the department’s Title VI investigation of the sheriff’s office.

A federal grand jury has returned an indictment in Alexandria, Va., charging five individuals with one count of conspiracy and five substantive copyright infringement counts for their involvement with the Internet website NinjaVideo.net.

Matthew David Howard Smith pleaded guilty today for his role in founding a website that provided millions of users with the ability to illegally download copyright-protected movies and television programs.

Hana A. Beshara, 29, of Las Vegas, pleaded guilty today for her role in founding NinjaVideo.net, a website that provided millions of users with the ability to illegally download infringing copies of copyright-protected movies and television programs in high-quality formats.

Joshua David Evans, 34, of North Bend, Wash., and Jeremy Lynn Andrew, 33, of Eugene, Ore., pleaded guilty today for their roles in NinjaVideo.net, a website that provided millions of users with the ability to illegally download infringing copies of copyright-protected movies and television programs in high-quality formats.

Justin A. Dedemko, 28, of Brooklyn, N.Y., pleaded guilty today before U.S. District Judge Anthony J. Trenga in the Alexandria Division of the Eastern District of Virginia.

The seven-count indictment alleges that Michael Moore, 44, of Chadds Ford, Penn., infringed the copyright protected works during seven six-month periods between May 2006 and June 2010.

Following a comprehensive investigation, the Justice Department today announced its findings in the ongoing civil rights investigation of the Maricopa County Sheriff’s Office.

"As outlined in our findings letter, we found reasonable cause to believe that MCSO engages in a pattern or practice of violating the Constitution and laws of the United States in 3 areas," said Assistant Attorney General Perez.

Hana Amal Beshara, 30, of North Brunswick, N.J., was sentenced by U.S. District Judge Anthony J. Trenga in the Eastern District of Virginia.

Seven individuals and two corporations have been charged in the United States with running an international organized criminal enterprise allegedly responsible for massive worldwide online piracy of numerous types of copyrighted works, through Megaupload.com and other related sites, generating more than $175 million in criminal proceeds and causing more than half a billion dollars in harm to copyright owners.

Matthew David Howard Smith, 24, of Raleigh, N.C., was sentenced today in Alexandria, Va., to 14 months in prison for his role in founding NinjaVideo.net, a website that provided millions of users with the ability to illegally download high-quality copies of copyright-protected movies and television programs.

The Department of Justice and the Department of the Interior announced today that Freeport-McMoRan Corporation and Freeport-McMoRan Morenci Inc. have agreed to pay $6.8 million to settle federal and state natural resource damages claims related to the Morenci copper mine in southeastern Arizona.

The Department of Justice filed a civil lawsuit in federal court today against Maricopa County, the Maricopa County Sheriff’s Office (MCSO) and Sheriff Joseph M. Arpaio, arising from unconstitutional and unlawful actions by the defendants.

Sean M. Lovelady, 28, of Pomona, Calif., pleaded guilty to one count of conspiracy to commit criminal copyright infringement.

"Today, the Department of Justice did something it has done only once before in the 18-year history of our civil police reform work; we filed a contested lawsuit to stop discriminatory and unconstitutional law enforcement practices," said Assistant Attorney General Perez.

A Pennsylvania man pleaded guilty today to conspiring to willfully reproduce and distribute tens of thousands of infringing copies of copyrighted works without permission, including infringing copies of movies before they were commercially released on DVD, Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division, U.S. Attorney for the Eastern District of Virginia Neil H. MacBride and Special Agent in Charge John P. Torres of U.S. Immigration and Customs Enforcement Homeland Security Investigations (ICE-HSI) in Washington, D.C., announced today.

"We look forward to welcoming these new additions to our nation's law enforcement community - and to building on the partnerships, and record of success, that we've established here in Philadelphia and beyond," said Attorney General Holder.

Pratt &s first modern military attack helicopter, the Z-10.

A New York man pleaded guilty today to conspiring to willfully reproduce and distribute tens of thousands of infringing copies of copyrighted works without permission, including infringing copies of movies before they were commercially released on DVD.

"Providing information, strengthening police-community relationships, and protecting officers – these are all ways the Office of Justice Programs is working to support law enforcement," said Acting Assistant Attorney General Leary.

"We realize that the protection of our communities, in so many ways, falls directly on your shoulders. But you are not in this alone. If there is one idea that you walk away from this conference with, I hope it will be that we at the Justice Department are your partners in this effort," said Deputy Attorney General Cole.

"I appreciate the various agencies and backgrounds here today – from counterparts within the federal government, to chiefs and sheriffs and their rank and file, plus practitioners, analysts and researchers from numerous institutions and organizations. It’s that collaborative effort that will drive what Barney mentioned earlier – an evolution of policing," said Acting Associate Attorney General West.

Jeramiah B. Perkins, 39, of Portsmouth, Va., pleaded guilty to one count of conspiracy to commit criminal copyright infringement.

Willie Lambert, 57, of Pittston, Pa., was sentenced today by U.S. District Judge Arenda L. Wright Allen in the Eastern District of Virginia to serve 30 months in prison, three years of supervised release and $449,514 in restitution, jointly and severally with co-defendants. Sean M. Lovelady, 28, of Pomona, Calif., was sentenced today by Judge Wright Allen to 23 months in prison, three years of supervised release and $7,500 in restitution.

A third member of the Internet piracy group “IMAGiNE” was sentenced today to 40 months in prison, and a fifth member of IMAGiNE pleaded guilty today for his role in the conspiracy.

The leader of the Internet piracy group “IMAGiNE” was sentenced today to serve 60 months in prison.

The Justice Department announced today that it will monitor the municipal election on March 12, 2013, in the town of Guadalupe, in Maricopa County, Ariz., to ensure compliance with the Voting Rights Act of 1965.

A member of the Internet piracy group “IMAGiNE” was sentenced today to serve 23 months in prison.

It is our hope – it’s definitely our belief – that these resources will offer public safety agencies here in Oakland and throughout California some much-needed assistance to address major issues like homicides, gang crimes, youth violence, and crimes against children.

That's why we are all gathered here this morning. Under the leadership of Attorney General Eric Holder, the U.S. Department of Justice has used a variety of tools to respond when law enforcement misconduct is uncovered. Those include everything from technical assistance provided by our Office of Justice Programs and our COPS Office to full-fledged enforcement actions by our Civil Rights Division and U.S. Attorney's Offices around the country, and everything in between.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

From : Communities>>Regulatory Open Forum
Hi everyone, As currently drafted,  the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More]

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
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Many thinks to Lisa Olson for sharing her insights with me.

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

Nov 24, 2019

The Harvard Project on Climate Agreements will conduct two panel events at the Twenty-Fifth Conference of the Parties (COP-25) of the UNFCCC in Madrid, Spain during the week of December 9, 2019. In addition, Professor Robert Stavins, Director of the Harvard Project, and Professor Joseph Aldy will speak at several events hosted by other organizations.