Title: Seniors, Getting Off the Sofa Brings Big Health Benefits
Category: Health News
Created: 3/5/2020 12:00:00 AM
Last Editorial Review: 3/6/2020 12:00:00 AM

In this issue of Genes & Development, Lu and colleagues (pp. 663–677) have discovered a key new mechanism of alternative promoter choice that is involved in differentiation of spermatocytes. Promoter choice has strong potential as mechanism for differentiation of many different cell types.

If you’re excited and in good shape to buy a home, self-made millionaire Barbara Corcoran says these are the five steps for you to take.

Many landlords are quite reasonable when it comes to giving back your security deposit. However, you should still take the necessary precautions in order to ensure you get your money back.

When it comes to building a retirement nest egg for the future, property is still regarded as one of the safest long-term investments.

Getting less sleep for five nights in a row can make you view other people’s expressions more negatively, including facial reactions seen over video calls

Excerpted from Khullam Khulla by Rishi Kapoor with Meena Iyer,...

The post “Curiously As I Got Older, The Offers Kept Getting Better” – Rishi Kapoor On His Second Innings appeared first on Man's World India.

Microsoft's all-in-one Office app will pick up iPad mouse support sometime this year.

Follow our live coronavirus updates HERE Coronavirus: The symptoms

A couple have been fined after getting stranded on a rock on the Scottish coast during the coronavirus lockdown.

A woman in her 40s was allegedly gang-raped after police quarantined her in a school overnight in India.

An aquarium in Japan has urged the public to video-chat their eels, who are forgetting that humans exist.

Gordon's alive! And he looks better than ever.

In times that have kept golfers away from courses and ranges, players had to get creative.

With more Australian artists being asked to play for free in the lockdown, many are asking if it might do more harm than good

If live music died in mid March, it’s sure been noisy at the funeral. On platforms old and new, live gigs performed at home have streamed from trickle to tidal wave, breaking over the mobile devices of captive audiences. Global gig guide aggregator Bands In Town has added a livestream dropdown, and a new Australian state has been ceded by Eventfinda and tucked alphabetically between Victoria and Western Australia: the state of “Virtual”.

For fans it’s been fun. We’re loving seeing musicians’ pets and plants and enormous fingers fumbling for the flip screen button and, unless we’ve bought a URL ticket, there’s scandalously little to lose by dropping into, and out of, a show.

Continue reading...

MTV, Nickelodeon, Paramount Network and TV Land are among the channels launching on YouTube TV in the coming months.

An obsession with tracking our nocturnal habits is keeping us awake at night, says Katie Strick

In the latest in our series of reflection and tales of lockdown, Laura Hampson moves back in with her brother and discovers how much can change in a decade

Judge Alison J. Nathan has ruled that the 66-year-old comedian is the creator of the show.

Chelsea and Australia striker Sam Kerr believes the coronavirus pandemic has put paid to any plans her national team-mates have to get pregnant in the next five years.

Five Dock is divided over the news a new train station will be built in the heart of the suburb with some fearing a repeat of the CBD light rail disruptions, while others looking forward to the economic injection from better transport.

New episodes return May 6 at 9/8c.

Snap's stock took a tumble after a disappointing year-end earnings report, but analysts say there's ample reason to think the company's upward trajectory will continue.

While tough coronavirus restrictions have saved thousands of lives, Scott Morrison says the country is now in a position to start clawing back some of the $4 billion lost every week that restrictions continue. Here are the key takeaways from his press conference.

IT’S official — you’re getting poorer as we speak. For the first time since 2014, the interest paid on savings accounts has fallen below inflation rate.

In "Becoming Kim Jong Un," former CIA officer expands our understanding of North Korea's dangerous, precarious regime by taking its leader seriously

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be […]

Exercise is good for the immune system but, as with anything, balance is key and this is especially the case when it comes to matching the type and level of activity with the right nutrition, as will be expertly explained in NutraIngredients' upcoming webinar.

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.



1.  Come to the Audit Prepared
This seems obvious. However, more often than not, quality auditors step into the supplier’s lobby without doing their homework. Ask yourself the following questions: Why am I auditing this supplier? Is this supplier new to my company or one that we have used before? If used previously, have I read over the audit observations as well as the supplier’s responses and do I understand them? Which audit observations do I suspect would be the most challenging for the supplier to address and which are most important to my company’s requirements for this product? Have I reviewed previously executed production batch records and testing data and are there issues that need to be resolved? Are their deviations and CAPAs to follow up on?

Your understanding the supplier’s work proposal is of great value in refining the scope of the audit. Ask yourself:  Which of our products may be manufactured and tested here and which strengths (e.g., potency) will be produced? Which equipment is likely to be used? For a tablet production, the equipment train could include balances, blenders, roller compactor, spray dryer, solvent-rated oven, comils, tablet press and tooling, gravity feeder, coating systems, de-duster, weight sorter, metal detector, tablet counter, etc. This list of equipment will assist you in requesting equipment records during the audit. 

2.  Stay On Point
Proper audit planning will help to keep the audit organized and adhere to the audit timeline. In advance of the audit, provide the audit host with a list of the technical, lab, and manufacturing staff you wish to speak with and the records you need to review. A well-organized host will have this available for your review. Stick to your audit agenda. This is critical. The best way to derail your progress is to spend precious time chasing down minor issues while glaring problems get little to no attention. Continually refer back to the audit agenda and remember to keep the content of your audit report in mind while executing the audit.


3.  Know Your Technical Expertise and Limitations
Many auditors have led previous lives in the laboratory or in manufacturing while others started their careers in quality assurance and may have little technical background with regard to equipment, manufacturing processes, GMP utilities and laboratory testing. Know your limitations and if necessary strengthen them by hiring an expert consultant to assist you during the audit.

A common problem area that is at best glossed over and at worst completely ignored during an audit is the CDMO’s compliance with GMP utilities requirements. All too often, this is due to the auditor’s lack of understanding of the operation, inputs and outputs, validation parameters, and periodic testing and maintenance requirements for utilities such as HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen and other gases used for operating equipment or used during processing activities in manufacturing. Typically, these areas are also less well understood by the CDMO’s employees and as a result noncompliance abound. 

Some GMP utilities may be connected to the facility’s building management system, while others may be stand-alone equipment. In either case, the CDMO should have records of alarms (e.g., out of specification or out of range conditions), an acknowledgement of each alarm by designated staff members, and documentation of corrective actions. The last item is key. This is where the execution of quality systems tends to fail. Make a point to request documentation of corrective actions for each utility alarm. 

Additionally, purified and WFI water systems along with gases, such as clean compressed air and nitrogen, require periodical sampling/testing at each point-of-use. Verify that the timelines (monthly, quarterly, or annual) for sampling and testing were performed as directed by the CDMO’s procedures. These timelines are typically not well adhered to. A clear understanding of all the operations of the supplier’s GMP utility management process will keep your thoughts clear during the audit and help identify areas that are in need of improvement. 

4.  The Auditor’s Job is to Identify the Good and the Bad (Not to Win the Debate)
An important goal of a supplier audit is to identify the supplier’s strengths and weaknesses and come away from the audit with a compliance assessment that your company can use to make important decisions. It is of no value to your company if the goal of the auditor is to show the supplier how much he or she knows by debating the fine points of compliance. GMP auditors with decades of experience generally avoid this competitive exchange as it is unproductive. Rather, it is more important to the spend the necessary time identifying compliance issues, making them known to the audit host in a professional manner, and taking detailed notes that assist in writing the audit report. Your company’s senior managers need to know the supplier’s good and not-so-good points; detailing all of these provides the greatest value. 

5.  Interview the CDMO's Lab Staff, Manufacturing Operators, and Shipping/Receiving Personnel
CDMO’s quality systems are generally written by managers and directors who have many years of industry experience. It is of utmost importance that staff members who execute these systems understand them if your company’s product is to be manufactured, tested, stored, and distributed in a compliant manner. Request to speak with manufacturing staff members who work on the production floor and are likely to work on your product. Ask them about the process they would follow to conduct lines clearance, charge powders to a blender, operate a spray dryer, use a comil, set-up of a tablet press, inspect tablets, use metal detectors, etc. Compare the information they provide to the CDMO’s SOPs to determine if the staff understands their jobs. Listen for phrases such as “I usually do it this way…” or “it’s a different every time but I typically set up the equipment like this…” These phrases reveal a lack of control and adherence to procedures. 

The Take Away
The audit itself lays the foundation for a relationship with the supplier and the take-away message should address the following questions: Will the supplier work to resolve the issues I’ve identified? Am I confident that the supplier will immediately notify and involve my company’s representatives when deviations occur during production or testing? Do the supplier’s quality systems and records meet my company’s requirements and those of regulatory agencies? How confident am I that the supplier will produce and/or test a quality product that my company can stand behind? Is the supplier simply a pair of hands or are they committed to be my partner in this product’s success? The answers will provide you with a comfort level in making the decision to move forward with the CDMO or to look to the their competition.  

*********************************************************************************

A version of this article was first published in Outsourced Pharma.

 About the Author
Greg Weilersbacher is the Founder and President of Eastlake Quality Consulting, a GMP consulting firm based in the Southern California area. Over the last 25 years, he has held director and vice president positions leading Quality Assurance, Quality Control, Analytical Chemistry, Materials Management, GMP Facilities, and Product Manufacturing in biotech and pharmaceutical companies. His unique experiences and technical background have led to the manufacture and release of hundreds of solid oral, sterile, and biologic investigational products to clinics in the U.S. and abroad. Email Greg at weilersbacher.greg@gmail.com.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Jan 8, 2020

The smoke is still clearing from the drone strike that killed Quds Force commander Qassem Suleimani, and from the Iranian retaliation against U.S. bases in Iraq, and any conclusions have to be tentative ones. But the history of U.S.-Iran conflict points to a narrow, and possibly dangerous, set of choices ahead.

Apr 13, 2020

The coronavirus pandemic has provided an opening for Donald Trump to attack transparency, voting rights, and accountability.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 13, 2020

The coronavirus pandemic has provided an opening for Donald Trump to attack transparency, voting rights, and accountability.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 13, 2020

The coronavirus pandemic has provided an opening for Donald Trump to attack transparency, voting rights, and accountability.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Build a simple PhoneGap app using Kendo UI Mobile.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Dec 18, 2019

Robert N. Stavins writes that the negotiations failed to reach one of their key stated goals: writing meaningful rules to help facilitate global carbon markets. As an economist, he sees this as a real disappointment — although not the fatal failure some portray it to be.

Apr 13, 2020

The coronavirus pandemic has provided an opening for Donald Trump to attack transparency, voting rights, and accountability.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 13, 2020

The coronavirus pandemic has provided an opening for Donald Trump to attack transparency, voting rights, and accountability.