FDA's New Process Validation Guidance Recommends Team Approach

Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit
Written by: Norm Howe | Distributed: 2011-09-12 | Word Count: 706 | Page Views: 537
Medical device manufacturers are always interested in knowing what FDA's next area of focus will be. Well, if you're an In Vitro Diagnostic manufacturer you might review your measurement systems.

How to Evaluate the Quality of a Dietary Supplement
Written by: Norm Howe | Distributed: 2010-11-02 | Word Count: 751 | Page Views: 5305 | Votes: 7 | Rating: 0.57
So, you've found a Dietary Supplement that exactly fits your special need. The information on the supplier's website appears to be consistent with everything that you've read and heard, and now you're ready to buy. But there are questions on your mind. "What is the quality of this product that I'm buying?" you ask. "Can I really trust this supplier?"

Off-Label Use of Medical Devices
Written by: Norm Howe | Distributed: 2010-06-22 | Word Count: 621 | Page Views: 5974 | Votes: 3 | Rating: 1.67
How can a medical practitioner decide whether a medical device that they want to use for one of their patients is legal and approved by the Food and Drug Administration? When a patient comes into a physician's office the patient is looking for the best, most modern care they can get. And a physician certainly wants the same thing.

A New Paradigm to Address the High Cost of Vendor Qualification
Written by: Norm Howe | Distributed: 2010-01-12 | Word Count: 1160 | Page Views: 4413 | Votes: 6 | Rating: 1.17
The assumption today is that a BETTER audit means a LONGER audit. There has to be another way. What's needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor's operation at low cost; something that can provide a more lasting measure of the vendor's performance than simply an audit...

The Myth of the Generic SOP
Written by: Norm Howe | Distributed: 2009-03-03 | Word Count: 687 | Page Views: 4787 | Votes: 8 | Rating: 2.00
What do you do when your boss tells you to write an SOP? Run and hide? Tell her how long it will really take to write one that's any good? If you choose the latter option, be prepared for this "helpful suggestion": "Why don't you just download a generic SOP from the internet?" You would have been better off taking the former option. Here's why.

The Evolution of Process Validation
Written by: Norm Howe | Distributed: 2009-01-27 | Word Count: 471 | Page Views: 6583 | Votes: 15 | Rating: 1.53
In November 2008, the U.S. Food and Drug Administration (FDA) published draft guidance on process validation. Entitled Process Validation: General Principles and Practices, this draft guidance replaces the previous guidance issued in 1987. What does this mean to you?

FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe | Distributed: 2009-01-21 | Word Count: 665 | Page Views: 6402 | Votes: 9 | Rating: 2.78
The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?

Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers
Written by: Norm Howe | Distributed: 2009-01-05 | Word Count: 440 | Page Views: 4407 | Votes: 8 | Rating: 1.38
How do small Dietary Supplement manufacturers comply with the new Dietary Supplement GMPs? The U.S. Food and Drug Administration (FDA) announced plans to publish a compliance guide that will provide assistance to small dietary supplement manufacturers.

Dietary Supplements Must Be Tested by Scientifically Valid Methods
Written by: Norm Howe | Distributed: 2008-09-03 | Word Count: 424 | Page Views: 5461 | Votes: 8 | Rating: 0.88
Are you a Dietary Supplement manufacturer trying to figure out what FDA means by "Scientifically Valid Method"? Here are some hints.

FDA Cracks Down on Fake Cures
Written by: Norm Howe | Distributed: 2008-08-14 | Word Count: 406 | Page Views: 5573 | Votes: 17 | Rating: 1.76
In an effort to crack down on charlatans who prey on the sick, the U.S. Food and Drug Administration (FDA) recently issued warning letters to 23 U.S. companies and two foreign individuals marketing a wide range of products that fraudulently claim to prevent and cure cancer.

All of Author's Articles on this site: Norm Howe Articles

How To Build a Strong and Powerful Business During a Recession
Written by: Trey McMartin | Distributed: 2011-11-10 | Word Count: 987 | Page Views: 6602 | Votes: 6 | Rating: 0.83
During a recession, most business owners pull the reins on advertising budgets, fearful of what tomorrow might bring... Those who remain fearful have forgotten what made them the success they are today... They have forgotten that they have a God-given talent to overcome the incredible obstacles in their paths.

SEO Lessons from Local Businesses
Written by: Trey McMartin | Distributed: 2011-11-09 | Word Count: 945 | Page Views: 6688 | Votes: 5 | Rating: 0.40
More than once in the six years that I have been providing SEO services for websites, I have had the opportunity to discuss with individual business owners their search engine optimization needs. Now and again, I run across an individual business owner who is quick to say that SEO is absolutely worthless. When confronted with such an absolute statement, I like to press for details. It has been my experience that people who speak in negative absolutes will have a horror story to share.

Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit
Written by: Norm Howe | Distributed: 2011-09-12 | Word Count: 706 | Page Views: 537
Medical device manufacturers are always interested in knowing what FDA's next area of focus will be. Well, if you're an In Vitro Diagnostic manufacturer you might review your measurement systems.

Online Fax - 10 Reasons To Get An Online Fax Service
Written by: Titus Hoskins | Distributed: 2011-09-12 | Word Count: 560 | Page Views: 542
Online faxing is the new more modern way to fax. If you or your company is not using an online fax service, here are 10 good reasons why you should get it.

Best Effort Essential for the Job Interview
Written by: Barbara Wulf MS, ACC, CPCC | Distributed: 2011-07-30 | Word Count: 676 | Page Views: 632
Interviewing will determine if you are the right person for the job. These tips will help you make the job interview a success.

Go Green With Your Career Search
Written by: Barbara Wulf MS, ACC, CPCC | Distributed: 2011-07-28 | Word Count: 636 | Page Views: 5457 | Votes: 4 | Rating: 0.50
Many of the qualities of green living, like recycling and sustainability, can apply to a career search, even if the career is not directly associated with green industries.

ReCareer in the Second-half of Life
Written by: Barbara Wulf MS, ACC, CPCC | Distributed: 2011-07-26 | Word Count: 525 | Page Views: 5458 | Votes: 5 | Rating: 1.20
Many of us worked the first half of our life to "fit" the job description. ReCareering is about finding the right fit, being selective, being creative, being fulfilled and being intentional about how you spend your time.

Up in the Air
Written by: Barbara Wulf MS, ACC, CPCC | Distributed: 2011-07-24 | Word Count: 678 | Page Views: 598
When looking for work or changing careers, go beyond researching on the internet and reading articles. Find out how you can learn from the art of listening and having a conversation.

Salon and Spa Owners: Which Monk Are You?
Written by: Dan Lok | Distributed: 2011-07-05 | Word Count: 477 | Page Views: 6234 | Votes: 7 | Rating: 1.00
Too many salon and spa owners are carrying around a lot hurts, regrets, guilt, past failures and fears about the future. But no one is forcing you to carry these emotional rocks, so put that sack down!

The Single Most Profitable Day You Spend on Your Spa or Salon!
Written by: Dan Lok | Distributed: 2011-06-30 | Word Count: 470 | Page Views: 6562 | Votes: 5 | Rating: 0.20
Salon and spa owners need to combine their marketing plan with marketing systems. A marketing calendar plans out strategies for a year, and is instrumental to the success of your spa or salon.

How To Write A 300 Page Book In Four Months
Written by: Mark Silver | Distributed: 2008-07-15 | Word Count: 821 | Page Views: 40100 | Votes: 8 | Rating: 1.38
There's a lot of hoopla about becoming an author of your very own business book. The promise of fame and fortune is very alluring. Yet your book remains perpetually 'about to be' written. Meanwhile your business has ground to a halt. Hmmm... might there be a better way to get a book written?

The Best Marketing Book I've Ever Read (You'll Be Surprised)
Written by: Judy Murdoch | Distributed: 2007-05-09 | Word Count: 1522 | Page Views: 37232 | Votes: 17 | Rating: 3.18
From time to time someone asks me to recommend marketing books. Here's one of my favorite marketing books that always surprises people. Curious? Read on.

The Bizarre History Of The HOLLYWOOD Sign
Written by: Morris Timlen | Distributed: 2008-11-05 | Word Count: 1211 | Page Views: 34802 | Votes: 30 | Rating: 2.70
The most famous sign in the history of mankind is the one that graces the side of the hill above Hollywood, California. As famous a landmark as the Christ the Redeemer statue in Rio De Janeiro, the Eiffel Tower in Paris France, the Great Pyramid of Giza in Egypt, The Church of the Savior on Blood in Saint Petersburg Russia, and the Statue Of Liberty in New York City, the Hollywood sign is known around the world as the symbol of the American movie industry.

What Does It Take To Be A Successful Salesman?
Written by: Casey Moher | Distributed: 2008-08-05 | Word Count: 930 | Page Views: 27439 | Votes: 84 | Rating: 3.17
In the course of my average workweek, I meet people who tell me that they have no sales experience, and very literally, many will tell me that they could not sell if their lives depended on it. Do you fit into this mold? Do you seriously believe that you can sell me on the idea that you cannot sell things?

The Future of the Office Photocopier Industry
Written by: Jennifer Robinson | Distributed: 2010-07-29 | Word Count: 635 | Page Views: 15825 | Votes: 39 | Rating: 2.00
Since Xerox first invented and sold the first commercial photocopy machine companies and organisations have paid for use of the machine on a cost per copy basis. This has traditionally included full maintainance and toner supplied under a service agreement. In-fact the office photocopier is unique in the fact its one of the only pieces of equipment that comes without a warranty from new. But photocopier expert Online Connect UK claim all that is about to change.

Never Write A 'Thank You' Letter Again
Written by: Perry Maisin | Distributed: 2008-08-12 | Word Count: 971 | Page Views: 14876 | Votes: 22 | Rating: 2.09
When I was in graduate school, I had a friend who interviewed at fortune 500 companies and succeeded at landing a great job. One day, I saw him sitting in the student union with a stack of cards. The cards said 'thank you'. He opened each card and signed his name. The inside of the card was blank. I asked him what he was doing and he told me that it was important to send a 'thank you' to every person you interviewed with. He believed that that was the difference between getting the job and being passed over.

Selecting Between a 401(k) And 403(b) For a Nonprofit
Written by: Daniel Lamaute | Distributed: 2007-10-11 | Word Count: 333 | Page Views: 14540 | Votes: 22 | Rating: 2.27
Newly released IRS regulations impose several new requirements and fiduciary responsibilities on employers with 403(b) plans. While the regulations generally don't take effect until January 1, 2009, there are some provisions that apply sooner.

Conducting Effective Career Aspiration Discussions with Employees
Written by: Andria L. Corso | Distributed: 2010-03-10 | Word Count: 690 | Page Views: 13559 | Votes: 12 | Rating: 1.33
Enhance your talent management and development programs through conducting career aspiration discussions with your employees. Find out where they want to grow their career to determine if it matches your business needs. This will enable you to differentiate your employee development to grow the future leaders of your company.

Top Ten Personal Habits
Written by: Laurel Vespi | Distributed: 2009-09-08 | Word Count: 427 | Page Views: 13258 | Votes: 12 | Rating: 2.08
Successful people have a regular routine of daily or weekly habits that reinforce the things that are most important to them. By practicing a set of personal success habits, they maintain a positive outlook, keep focused on their priorities, have more energy, and a greater sense of satisfaction with life.

Pitch A No-Hitter With Baseball-Themed Flower Gifts
Written by: Wesley Berry, AAF | Distributed: 2007-12-25 | Word Count: 413 | Page Views: 11777 | Votes: 27 | Rating: 1.74
Want to send a gift to the baseball fan in your life that's sure to knock one out of the park? Send flowers with a baseball theme! Everyone loves flowers and when you personalize them to include the recipient's favorite hobbies, like baseball, they're sure to make an even greater impression.

Equal Opportunity Pizza Ordering
Written by: Rudy Vener | Distributed: 2007-10-19 | Word Count: 629 | Page Views: 5321 | Votes: 10 | Rating: 3.60
With online ordering, your menu and restaurant suddenly become accessible to both the deaf and blind customers in your community.

Lone Wolf --- Lead Wolf: The Evolution of Leadership
Written by: Rick Johnson | Distributed: 2006-07-20 | Word Count: 1826 | Page Views: 4396 | Votes: 19 | Rating: 3.47
Family owned organizations, both small and large, with succession issues, family preparation and second and third generation leadership issues have been subjected to the evolution of leadership. These organizations are often founded by an aggressive, highly talented entrepreneur. Many of the principles of leadership that helped build the success that the organization enjoyed in the past is not the type of leadership that will maintain that success through generations of ownership.

Get the Balance Right
Written by: Rich Thawley | Distributed: 2009-01-28 | Word Count: 638 | Page Views: 3929 | Votes: 15 | Rating: 3.33
Do you build your business around your family or your family around your business? The choice is yours.

Delegate Or Die: 6 Steps For Business Growth
Written by: Rick Sloboda | Distributed: 2007-05-08 | Word Count: 366 | Page Views: 3655 | Votes: 24 | Rating: 3.29
To achieve business growth, you need to focus on your strengths and hire others to take care of the rest. Unfortunately, entrepreneurs often fail to employ this fundamental business growth strategy. Here are six steps to help you delegate successfully.

Whose Restaurant Can You Find Online?
Written by: Rudy Vener | Distributed: 2007-07-09 | Word Count: 640 | Page Views: 5030 | Votes: 7 | Rating: 3.29
What is so significant about Pizza Hut's latest TV commercial?

Why Businesses Need Receivable Factoring In Cash Flow Management
Written by: Toby Seibert | Distributed: 2007-08-08 | Word Count: 866 | Page Views: 7288 | Votes: 7 | Rating: 3.29
In today's business environment, many businesses need to fine-tune the process of getting paid on invoices, in order to improve their cash on hand. Improving cash flow can be an ongoing challenge for businesses of all sizes, and it is an issue that must be addressed to ensure the long-term viability of the business.

Boost Retention And Referrals In Your Insurance Agency
Written by: Stephanie Cunningham | Distributed: 2007-10-23 | Word Count: 707 | Page Views: 2614 | Votes: 7 | Rating: 3.29
If you have ever stayed at a nice hotel, then you have probably seen the hotel's Concierge. The role of the Concierge is to assist guests with information and service to enhance their stay. What would happen if you took the idea of the Concierge and applied it to the way you service your agency clients?

Business School for Non-Business Minds: Got a NAICS Number?
Written by: Melissa Mashtonio | Distributed: 2008-04-15 | Word Count: 423 | Page Views: 5145 | Votes: 7 | Rating: 3.29
I’m a journalist. I spent a lot of my career in the news business. As my career has progressed, I’ve spent time at small and large companies, and I have sat through dozens of business meetings wondering what the heck the “money” people are talking about. They used acronyms as if they were a foreign language.

The Problem With Swiping Sales Copy
Written by: Scott Bywater | Distributed: 2009-12-03 | Word Count: 480 | Page Views: 5094 | Votes: 7 | Rating: 3.29
This is what people miss when they try to simply "swipe" sales copy from another advertisement.

Why 'Closing' Is Not The Most Important Part Of Making A Sale
Written by: Scott Bywater | Distributed: 2006-08-29 | Word Count: 553 | Page Views: 6320 | Votes: 31 | Rating: 3.26
If you ever thought that 'closing' was the single most important key to sales success, then pay close attention, because what I'm about to share may surprise you. Let me explain: