Ways to Prepare For a Real-Life FDA Audit

The inspection by FDA investigators sounds scary if your own internal auditing processes are weak and faulty. But, to understand FDA procedures and how to successfully pass their audits, you need to first understand the role of FDA investigators. The job of the FDA is to make sure the health of the common people is protected. It’s also their responsibility to ensure that the products launched in the market are effective and safe for the people to use and that there are no probable side effects of any new drug developed.

So, it’s obvious that their focus is upon sanitation, purity, quality, and a particular identity of the drug being developed. It also reflects why GMP or good manufacturing process has acquired so much importance for the FDA. There must not be any violation of the Food and Drugs Act. Furthermore, they are also supposed to make sure that no counterfeit or diverted drug is sold in the market.
Start your own auditing

However, you need not be scared of an FDA audit as there are simple ways you can improve the quality of your processes. The first such step is to start your own auditing. Your internal auditors can take charge and start monitoring the processes. They should not be restricted to making recommendations. In fact, they should be authorized to change processes. Senior managers should also be kept in the loop to improve processes and to make sure that corrective steps are taken well in time and according to the schedule.

Internal auditing processes are very effective in improving the overall processes. You can hire third-party auditors from outside to make sure that the teams are exposed to severe mock audits. This works both ways: it brings you the complete analysis of the procedures and performance of your company; and it also works well for the training of your teams for the actual formal audit.

Don’t underestimate the experience and skills of third-party auditors as far as their ability to improve your procedures is concerned. It goes beyond passing the audit. Their inputs and tips can provide you a good insight into the prospects of your company to grow into a more successful organization.

Dig Deep for Small Business Ideas

Success is how you define it.

Finding the right idea to bring you that success takes a willingness to be patient, good timing, and a lot of research.

And there’s nothing wrong with taking your time, being careful trying to figure out which small business ideas are best.

If you rush this process, you’re bound to come up with a business that doesn’t excite you at all.

You’ll be bored.

You won’t reach goals and it will become more like a job … maybe even harder!

You’ll feel like you would working for someone else. (You don’t want that again, do you?)

First, Figure Out What You Really Want

Starting off, you really have to force yourself to relax. I know what it’s like being very, very unhappy at a job. And I can tell you from first-hand experience that walking away from a well-paying job and jumping into your own business is stressful.

But if you carefully plan your “escape,” it will make it that much better!

Set Your Short-Term Goals

Maybe you want to make a ton of money and drive around in a BMW.

Or maybe you just want the freedom to enjoy your family or friends. Or perhaps it’s just a matter of being in control of your life — being able to do whatever you want, whenever you want.

Whatever your long-term goals are, first you have to concentrate on the shorter term goals before you can begin to see that “big picture.”

It’s up to you.

But understand that the type of business you start will play a roll in whether or not you meet your goals — both short and long-term.

If you’re trying to startup a part-time venture while working full-time for someone else, you’re going to have to set daily goals to try and squeeze in a few hours of work every day, often before and after work! (I used to get up at 4:30 in the morning, go to my full-time job at 8:30, come home at 5 or 6 and get right back to work on my new business … and I loved it!)

But if it’s a small business idea you came up with on the ride home and it doesn’t really “drive” you, it’ll make reaching your short term goals — often the hard part — a heck of a lot more difficult.

What are Your Long-Term Plans?

That big picture includes, more than anything, something you can see yourself doing every day. Something that — even on weekends — you love to do.

And even though it is something you love to do, make sure it will feed your long-term plan. And you won’t know that until you know what your long term plan actually is!

For instance, if your plan is indeed to make a lot of money and retire at a young age, you’ll obviously have to look at small business ideas that are highly profitable.

This would include mostly business-to-business models. There is typically more profit selling to businesses (a product or service) unless you make it big in the consumer market.

Why would the business-to-business market be more profitable? Because a business would be more willing to invest in a product or service (that may even be a write-off) versus the consumer market which is more “luxury” driven. Meaning, consumers base a lot of their buying decisions on want instead of needs.

It’s also a financial issue.

A larger business can pay a $300 invoice without thinking about it whereas a consumer getting a $300 bill may sweat a little more.

This is just an example of understanding your long-term goals so you can look closer at a finite number of business ideas to get you closer to where you want to be.

And if you go ahead and hang your “open for business” sign and then realize, “Oh, I can’t make that much money doing this!”, you’ll only be taking one step forward and two steps back.

Grab a Pad … Ideas Will Come and Go

Because — like all entrepreneurs — you’re a thinker, you’ve always got ideas popping into your head. Probably more than you can handle (the brain only has so much room, right?).

That’s why you should always keep a notebook by your side.

Sure, some of the best ideas get written on a cocktail napkin. But you’re better off trying to give these ideas more permanence. And having a notebook dedicated to your small business ideas will give you a growing and buildable “diary” to use when you’re good and ready to go for it!

And once you start putting your ideas in writing, you’ll find yourself getting into the habit of using your notebook more and more. It’s like anything else that takes practice.

The more you do it, the better you get at finding the best small business ideas. And each idea will help you grow more specific or “niche” ideas.

Become a Private Investigator!

What you want to do is really learn how to research. You’ve got to dig — and dig deep — to determine what business really could work best for your success.

Not only do you have to know who you are and what’s going to drive your personality the most, but you also need to think about what sells.

What type of business can be profitable?

Too many people make the mistake of looking at only one aspect of starting a small business. If you love parakeets and you’re passionate about them, it doesn’t mean you’ll be able to open up a store in your town without knowing if anyone else likes them!

As a side note, starting an internet business allows you a greater opportunity to build a business around something you’re passionate about. If it’s parakeets you love, you’ll find more people on the internet with your same passion than you would in your own backyard. For some great information about finding your passion on the internet, click here

You research should include looking at what other businesses are doing (successfully and not so successfully) in your city or town.

Look at small businesses and even what the “big guys” are doing.

Maybe you could create a smaller business with a personal touch that the “big guys” are typically missing out on (no matter how hard they try.)

Figure out more about what makes you tick …

What kind of hobbies do you have, if any?

What kind of magazines do you enjoy?

What do you like to do most in your “free” time?

What was the best job you ever held? Even if it’s one you had when you were a kid, you may find a business in something you know and love — but don’t even realize it yet!

Business Ideas Are Everywhere

Start to think about needs in your town or city. Is there something missing? Is there a need or a product or some type of service people would use that they “want?”

What is the majority age population in your city or town? Is it mostly seniors? (a huge market because they are more active and living longer than ever.) Or is your community made up of younger families?

Check out the local sections in your paper. Read the Lifestyle and Arts section. (I always find articles about local business people who have started businesses.)

Look at local and state businesses. Look at consumer trends and what people “want.”

Is there something other businesses in your area need? Don’t be afraid to go around and ask!

Think about concerns we all have in the world today.

There are so many opportunities out there, waiting for like you to step up and get started with a new business!

Don’t be afraid to ask!

This is where your friends, family and neighbors come in. Ask them to give you their number-one need. A product or service that’s “hard-to-find.” A complaint about what’s missing from their lives.

How many times have you looked for something — a product or service — and had to travel a long distance to get it?

Answering questions will give you plenty to think about and some good material for your notebook.

And if you’re interested in the business-to-business market, you could always put together a survey and mail it out to local businesses. Give them an incentive (a low-cost, high value gift) and find out what they really need to help them improve their business.

You may find that all of the local businesses in your area need someone to take care of local deliveries. Or someone to help them type or use their computer more effectively..

How To Set Prices

Here’s the thing about pricing… it really doesn’t matter what the price of a product or service is. The only thing that matters is your belief in the price and your ability to transfer that belief to a customer.

I’ve seen two identical bottles of water selling anywhere from $0.99 to $4.99. It all depends on where you buy it. And there doesn’t seem to be a shortage of buyers at either price.

I’ve seen coaching programs priced from $50 an hour to $100,000 for a year.

It all comes down to how valuable the person who set the price sees their product or service.

Let’s look at the water. Some things to consider are:

  • Availability: How easy it is to get and if there are other stores selling the same product nearby.
  • Demand: How much demand is there for water. How badly did his potential customers want the water? Do they need to encourage clients to buy it? Would it be a quick add on “no brainer” type of purchase or would customers come into the store just to buy water?
  • Quality or uniqueness of product: Was there anything special about the water that he was selling? Was it available elsewhere?
  • Importance of the product is to the potential customer. What would happen to the potential customer if they did not have the water? Were there other options available to them? What would having the water do for the client? How would they feel, or what would they experience, (or not experience) because they had it?

So what about you? How do you price your products or programs? Especially if what you sell is a service and not a physical product?

I was speaking with one of my top-level clients about pricing one of her programs. She was concerned that the price was too high, that she wouldn’t be delivering enough value for the price and wanted to add more features to the program (there is more about features further on in this article).

I listened and when she was done I asked her if she believed in herself. Did she believe that the content that she planned to deliver would serve the people who registered for the program? I asked her if she believed that she was qualified to teach that material?

She told me that without a doubt she was qualified to teach the material and that she was certain that the material had the potential to change the lives of the people who joined the program.

What specifically are you offering? How many sessions or classes is the program? Is the material being offered virtually or in person? Is it a group experience? Are you going to work one-on-one with people? Is it a self-guided program or are you going to deliver the material?

What do they get, what are they able to do, what do they experience or what do they no longer experience because of the program that you offer?

This is very important. It might sound crazy but the people who buy your products and programs are not buying your products or programs, they buy the experience they get by using your products or programs. For instance, you do not buy a chocolate bar; you buy the experience you have when you eat the chocolate bar. You do not buy a gym membership; you buy the experience you have at the gym and more likely, the results you get from what you do at the gym.

Is this program a client’s first experience with you? Do you want it to be a “no-brainer” purchase? Is the program meant to be a pathway to other programs? Do you want the program to be more of an exclusive program? For instance, I have a variety of programs and products priced at various levels. Some are priced to sell. These programs give people an opportunity to get to know me and give me an opportunity to offer them higher-level programs when appropriate. Other programs are more exclusive and are at higher prices.

I can’t stress how important this is. So many people want to “validate” their prices by offering more features. They throw in extra bonuses, add more calls or classes or give more of their own time. Take a moment to consider two things. First: What do you want to give? How much time and energy do you want to put in? What is going to work for you? Second: What does your client really need? What will solve your client’s problem? Most likely your client does not need more than the basic program. It is more likely that you want to put more in to make you more comfortable with the price.

Now we go back to our water example and availability, demand, quality and importance of your product.

Availability: Does anyone else offer something similar to you? Most likely yes. What is their price? Who are their customers? Do you want to compete with them? How many spots do you have to offer in your program? Do you want many people in it or just a select few?

  • Demand: There must be a demand for your product. If there is no demand then do not offer it. I like to create products or programs when people ask me for them. That way I know that there is a demand.
  • Quality: Is the quality of your product Wal-Mart or Nordstrom? Both companies make a lot of money and both have very sound markets. They key for you is to know which market you want to cater to and price your products and services accordingly.
  • Importance: What will your customers experience because they bought from you? What do people who do not buy your product miss out on?

What it all comes down to is that the price you put on your product or service is what you believe it is worth. The trick is to believe in your product, and to market it confidently with a focus on the benefits your clients get through it so that your clients see the value in it that you do.