vis

Remarks by Acting Assistant Attorney General for the Civil Rights Division Jocelyn Samuels at GE Capital Retail Bank Press Conference

The settlement resolves claims that the bank discriminated against Hispanic borrowers by excluding them from two credit card debt-repayment programs. It is the federal government’s largest credit card discrimination settlement in history.




vis

Caribbean-Based Investment Advisors and Attorney Plead Guilty to Using Offshore Accounts to Launder and Conceal Funds

Joshua Vandyk, a U.S. citizen, and Eric St-Cyr and Patrick Poulin, Canadian citizens, have each pleaded guilty to conspiring to launder monetary instruments, the Justice Department and Internal Revenue Service (IRS) announced today



  • OPA Press Releases

vis

Justice Department Announces Proposed Amendment to Americans with Disabilities Act Regulations to Expand Access to Movie Theaters for Individuals with Hearing and Vision Disabilities

The Justice Department announced today that Attorney General Eric Holder has signed a Notice of Proposed Rulemaking (NPRM) to amend the Title III regulation for the Americans with Disabilities Act (ADA) to require movie theaters to provide closed movie captioning and audio description in order to give persons with hearing and vision disabilities access to movies



  • OPA Press Releases

vis

The following joint statement was released Friday by FBI Special Agent in Charge William P. Woods, U.S. Attorney for the Eastern District of Missouri Richard G. Callahan and Acting Assistant Attorney General for the Civil Rights Division Molly Moran

The former chief executive officer of Hanover Corporation was sentenced today to serve 14 years in prison, to be followed by three years of supervised release and ordered to pay $14,784,983.75 in restitution for orchestrating an $18 million Ponzi scheme



  • OPA Press Releases

vis

South Carolina Man Pleads Guilty to Fraud in Foreign Labor Contracting, Visa Fraud and Wage and Hour Violations

Acting Assistant Attorney General Molly Moran for the Civil Rights Division and United States Attorney Bill Nettles announced today that Reginald Wayne Miller, of Marion, South Carolina, has entered a guilty plea in federal court in Florence to fraud in foreign labor contracting. Additionally, Miller entered a guilty plea to visa fraud and wage and hour violations. United States District Judge R. Bryan Harwell of Florence accepted the guilty plea and will impose sentence after he has reviewed the presentence report which will be prepared by the U.S. probation office.



  • OPA Press Releases

vis

New England Compounding Center Supervising Pharmacist Arrested at Logan International Airport

A Canton, Massachusetts, man was arrested today at Boston's Logan International Airport in connection with the ongoing criminal investigation of New England Compounding Center by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts.



  • OPA Press Releases

vis

New Jersey Man Pleads Guilty to Operating Fraudulent Visa and Payroll Scheme to Facilitate Illegal Immigration

A New Jersey man pleaded guilty today to orchestrating an eight-year scheme to falsify employment certifications to facilitate the illegal entry of Indian immigrants into the United States and to filing a false tax return.



  • OPA Press Releases

vis

Caribbean-Based Investment Advisor Sentenced for Using Offshore Accounts to Launder and Conceal Funds

Joshua Vandyk, an investment advisor, was sentenced today to serve 30 months in prison for conspiring to launder monetary instruments, the Justice Department and Internal Revenue Service announced.



  • OPA Press Releases

vis

Assistant Attorney General Caldwell Announces Sung-Hee Suh to Serve as Criminal Division Deputy Assistant Attorney General

Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division today announced that Sung-Hee Suh has been appointed to serve as Deputy Assistant Attorney General overseeing the Appellate, Capital Case and Fraud Sections.



  • OPA Press Releases

vis

Attorney General Holder Announces Joyce Branda to Serve as Acting Assistant Attorney General for the Civil Division

Attorney General Eric Holder released the following statement Thursday announcing Joyce Branda as Acting Assistant Attorney General for the Civil Division.



  • OPA Press Releases

vis

Remarks by Assistant Attorney General for the Criminal Division Leslie R. Caldwell at the Taxpayers Against Fraud Education Fund Conference

Qui tam cases are a vital part of the Criminal Division’s future efforts. We encourage you to reach out to criminal authorities in appropriate cases, even when you are discussing the case with civil authorities. The sooner we on the criminal side learn about potential criminal conduct, the sooner we can investigate.




vis

Remarks by Principal Deputy Assistant Attorney General for the Criminal Division Marshall L. Miller at the Global Investigation Review Program

A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite.




vis

Former Director of General Services Administration Division and Husband Indicted for Fraud and Nepotism

ALEXANDRIA, Va



  • OPA Press Releases

vis

New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

Continue reading »




vis

New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

Continue reading »




vis

New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

Continue reading »




vis

New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

Continue reading »




vis

New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

Continue reading »




vis

APEC to Bring a New Vision in 2020

APEC’s 21 member economies will finalize in 2020 a new vision for the forum’s next phase, said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria.




vis

SOP Revision, SWAT-Style

By Laurie Meehan

SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale.  So why would you want to read about it?  Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful.  Maybe we have.

The SWAT Technique

Last month, we worked with a company to revise a set of SOPs using a technique we call SWAT.  (Any edgy appeal that name might have otherwise had will be immediately dulled by its acronym expansion: “SOP Working Analysis Team.”  It’s the best we could do.  Don’t judge.)

The goal of the SWAT technique is to revise the most documents in the least time, while preserving friendships, sobriety, and original hair color.  The heart of SWAT is an immersive, multi-day working session in which participants discuss SOP revisions and incorporate them in real time.  Careful planning, thorough preparation, and commitment from management and participants are keys to keeping the SWAT session productive.

It’s Not For Everyone

Up front, we need to say that SWAT won’t work for every organization.  While the size of the company may not be important, the size of the working team needs to be fairly small.  Also SWAT won’t work for every set of SOPs.  The documents need to be part of a natural grouping – a set of similar procedures – and not a random collection.

But in the right situations, SWAT works very well.  Last month, we conducted a 2-day SWAT session with a client’s QA department to revise a set of 10 auditing SOPs.  We’ve also successfully used the technique with ClinOps teams, for example, to revise sets of monitoring SOPs.

SWAT Planning and Preparation

The SWAT process begins with central planning.  A coordination team selects a logical grouping of SOPs to revise, and assembles a list of specific revisions to be made.  Where it’s not possible to provide specific revisions, instructions and guidelines are developed, such as “remove audit report distribution details” or “update to reflect new file safeguarding practices.”

Each SWAT participant is assigned an SOP from the revision set.  The participant doesn’t need to be the author of record, but must be knowledgeable enough to “represent” the SOP – to learn the document well and understand how it’s similar to the other SOPs in the revision set and in what ways it’s unique.  Based on this understanding, prior to the SWAT session, participants make applicable revisions to their individual documents using the information received from the coordination team.  Participants should also note questions and any open issues appropriate for SWAT discussion using inline comments. 

SWAT Session

The result of the SWAT session is a set of approval-ready SOPs.  The precise structure of the SWAT session to get you there depends on a variety of factors, such as how similar or dissimilar the SOPs are, the extent and complexity of the revisions, and whether subject matter expertise is concentrated or distributed among the group.  But all successful SWAT sessions we’ve conducted share these attributes:

  • Duration of 2 to 3 days.  Just long enough to accomplish the aggressive goal, just short enough to keep everyone from diving out the window.
  • Real-time revision.  The “SOP of the hour” is projected on a screen while participants sit in front of PCs and update their assigned SOPs accordingly.
  • Rigorous facilitation. It’s natural for discussions about company procedures to morph into other topics, such as business strategy or staffing requirements.  Discussion *will* get off topic.  When it does, the facilitator must act quickly to table it.  You can maintain a list of tangent topics on a flip chart, schedule a meeting to discuss the most pressing items, ring a cowbell, blow an air horn, or drop a quarter in the “Diversion Jar” and move on, but keep those conversations out of your SWAT session.  Save the war stories for dinner.
  • Commitment to the process.  Scheduling the session is one thing, but remaining dedicated to the session is an act of will. It’s so ridiculously easy for outside work to creep in.  Management and participants must be committed to carving out the time and keeping the barbarians at the gate.
  • Of course: Plenty of caffeine and yummy treats.

If you’ve ever worked on SOPs, you know there’s a big difference between done and almost done.  To help ensure you emerge from the SWAT session with the former, time must be allotted for participants to format, polish, and conduct a quality review.  If it’s possible to scare up some on-site administrative support, that could help expedite the process.

SWAT Benefits

When you look on your team’s Outlook calendar and see 3 entire days blocked out, it can seem like an awful lot of time devoted to SOP revision.  But SWAT really doesn’t take any longer than the usual process, it’s just more obvious.  Does SWAT take significantly *less* time?  Mmmm, not sure, but SWAT brings with it other benefits.

SWAT produces a more consistent set of SOPs.  Since every document is compared to every other, it’s easy to notice and correct incidental differences.

SWAT is a cross-training opportunity.  Participants enter SWAT knowing their own SOP very well.  They leave knowing the whole SOP revision set very well.

SWAT gets it done.  Auditors, how many times have you cited facilities for failure to revise their SOPs within the specified window?  It’s not because there’s a willful disregard for SOP procedures.  It’s because, in the real world of work, revising SOPs is seldom prioritized highly enough to get on anyone’s schedule until the end of the revision window encroaches or – oops – has passed.  But schedule a SWAT and they will come. (And because the effort is so visible and so obviously resource-intensive, no one wants to be the one to drop the ball.  Participants come prepared and the resulting documents are the better for it.)

SWAT is a lot more fun.  Revising SOPs on your own is really boring.  Revising them in immersive sessions with colleagues is significantly more enjoyable.  Gallows humor reigns supreme.  Copious amounts of chocolate are consumed.  Air horns are blown in celebration.  Friendships, sobriety, and hair color remain intact.  Participants live to write another day.



_______________________________________________________________________
Photo Credit:  Tenaciousme CoffeeArt, under Creative Commons License





vis

NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19

NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.

To read the whole article click on the headline




vis

Emergency Relief Package Yields Increased FDA Funding, OTC Revisions

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]




vis

Anti-Vaccination Activists Join Stay-At-Home Order Protesters

Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement.




vis

At protests, mostly white crowds show how pandemic has widened racial and political divisions

Coronavirus pandemic widens racial and political divisions




vis

Nomination of Candidates for Director and Audit & Supervisory Board Member (PDF: 163KB/3P)




vis

Nomination of Candidates for Director and Audit & Supervisory Board Member (PDF: 163KB/3P)








vis

IBPS RRB Office Assistant & Scale I, II & III Provisional List 2020 out: Check Final Results @ibps.in

IBPS RRB Provisional Allotment List & Final Result 2019-2020 out @ ibps.in. Check your result on direct link provided here. IBPS conducted the RRB Office Assistant & Officer Scale I, II & III recruitment exam in August 2019.






vis

The Syntrophy hypothesis for the origin of eukaryotes revisited




vis

High-purity orbital angular momentum states from a visible metasurface laser




vis

Δ<sup>9</sup>-Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial




vis

The Strategic Postures of China and India: A Visual Guide

Fueled by aggressive rhetoric from both capitals, Indian and Chinese ground forces engaged in a standoff between June and August 2017. The Doklam crisis, as it became known, stimulated introspection among officials and experts in both states about the future of their relationship. Politically, both strategic communities largely concluded that the peaceful resolution of border disputes is now less likely, forecasting more rivalry than cooperation. Militarily, Indian discussions on the strength of its military position against China in their disputed ground frontier areas have converged on the view that China holds the conventional and nuclear edge over India in this domain.

Based on our analysis of data on the location and capabilities of Indian and Chinese strategic forces and related military units, we conclude that this assessment of the balance of forces may be mistaken and a poor guide for Indian security and procurement policies. We recommend that instead of investing in new nuclear weapons platforms that our analysis suggests are not likely to be required to deter China, New Delhi should improve the survivability of its existing forces and fill the gap in global arms control leadership with an initiative on restraint and transparency.




vis

The Global Pandemic Has Spawned New Forms of Activism — and They're Flourishing

The authors have identified nearly 100 distinct methods of nonviolent action that include physical, virtual and hybrid actions.




vis

The Global Pandemic Has Spawned New Forms of Activism — and They're Flourishing

The authors have identified nearly 100 distinct methods of nonviolent action that include physical, virtual and hybrid actions.




vis

The Global Pandemic Has Spawned New Forms of Activism — and They're Flourishing

The authors have identified nearly 100 distinct methods of nonviolent action that include physical, virtual and hybrid actions.




vis

Análisis de los servicios 'a la carta' de las televisiones autonómicas españolas

Anton, Laura and Guallar, Javier Análisis de los servicios 'a la carta' de las televisiones autonómicas españolas., 2020 . In IV Congreso ISKO España y Portugal, Barcelona, 11-12 July 2019. [Conference paper]




vis

The Global Pandemic Has Spawned New Forms of Activism — and They're Flourishing

The authors have identified nearly 100 distinct methods of nonviolent action that include physical, virtual and hybrid actions.




vis

New Committee to Advise Bacow on Sustainability Goals

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.




vis

ART with high viscosity GIC and composite restorations in class II cavities: can they thrive in the post-amalgam era?




vis

Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies

This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world. 




vis

New Committee to Advise Bacow on Sustainability Goals

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.




vis

Study Group on Energy Innovation and the Transition to a Low-Carbon Economy: Advising Fortune 500 Companies

This study group will explore the role of the private sector in evolving energy systems, and how corporations might change in a climate constrained world. 




vis

New Committee to Advise Bacow on Sustainability Goals

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.




vis

New Committee to Advise Bacow on Sustainability Goals

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.




vis

New Committee to Advise Bacow on Sustainability Goals

Harvard University has created a Presidential Committee on Sustainability (PCS) to advise President Larry Bacow and the University's leadership on sustainability vision, goals, strategy, and partnerships. The Harvard Gazette spoke with committee chairs Rebecca Henderson, the John and Natty McArthur University Professor; John Holdren, the Teresa and John Heinz Professor of Environmental Policy at Harvard Kennedy School; and Katie Lapp, executive vice president, about why it is so important to act now; the role of the PCS in developing collaborative and innovative projects; and how the campus community can get involved.