As we approach Memorial Day this upcoming weekend, The Porch today pauses to honor the men and women that have served in our military service. And, we honor their families that have also sacrificed so much. I admit to being a softy about our military members and their families. I have probably never watched one of those videos about surprise returns from service without getting a tear in my eye. To all these individuals and their families, we honor you today.

There are many individuals in my family that have served in the US military over the past century or more. I know for sure of distant relatives that served in the US Civil War. My grandfather served in Europe during World War I. My father was in the Pacific during World War II. I have brothers-in-law that served during the Viet Nam War. My brother served in the Navy. I have a nephew that served several years in Europe and another, a veteran of many deployments to the Middle East, and his daughter currently serving. I have many friends that have served. So, I know first-hand of the sacrifices that are required, and freely given, by those that serve.

However, I also want to recognize the families of those that have actively served our country. They are often the forgotten heroes. Can you imagine being a mother of one or more children serving during World War I or II – a time when immediate communication was not possible like it is today – hoping and praying for months that your son or daughter was safe without knowing for sure? Can you imagine going to the door of your home to be met by representatives of the military there to inform you that a son, daughter, or other loved one was killed? Can you imagine the mental and emotional scars that so many family members still have today as a result of their sacrifices?

Many in our society today remain scarred by military service… some with physical scars, others with scars not so visible. Long periods of absence harm families, marriages, and, sometimes, the mere ability to cope with life. Yet, because these scars are not visible, they are easy to forget or ignore.

To all those that have made these sacrifices and that bear the scars to prove it, we give our most sincere and heartfelt thanks. You are a hero!

John Gordon was a respected general for the South in the Civil War. After the war, he was running for the U.S. Senate, but a man who had served under him in the war, angry over some political incident, was determined to see him defeated. During the convention, he angrily stamped down the aisle with his anti-Gordon vote in hand. As he saw Gordon sitting on the platform, he noticed how his once handsome face was disfigured with the scars of battle. Overcome with emotion, he exclaimed, “It’s no use; I can’t do it. Here’s my vote for John Gordon.” Then, turning to the general, he said, “Forgive me, General. I had forgotten the scars.”*

To those of you that bear the scars of service to our country – whether you served directly or as a family member – you are honored. We experience the freedom we have this Memorial Day week because of you. Thank you!

And, to those of you that feel your scars could never allow you to be free or because you have lost hope, please take a look at this previous post from The Porch called, What is your hope? Here, you can read about someone else that bears scars for us and who can give us a different kind of freedom.

 

* From Steven Cole at this link: https://bible.org/seriespage/lesson-107-king-cross-luke-2326-49

Today, The Porch takes you behind the scenes of a typical FDA inspection. Many that are new to FDA inspections (and, most global regulatory inspections would be similar) and even some that have been around the block are not aware of some of the interactions that occur during these inspections. I have been personally involved in over 100 of these inspections myself, most of which I was the lead company representative. Plus, I have a number of friends and acquaintances that are or were FDA investigators, so I think I can paint a pretty accurate picture of what really goes on during these inspections.

Following are ten sets of questions/answers around typical FDA investigators and the inspections they conduct. Keep in mind that these answers are for TYPICAL situations, not all.

1. What preparation occurs by the FDA investigator prior to the presentation of the FDA-482 form for an inspection at your facility? Most FDA investigators do spend time preparing ahead of the inspection. In some cases, this preparation is extensive and may require a week or more. Investigators will examine the firm’s file and review the most recent inspection and any company responses or correspondence. They will note the verbal recommendations made during the last inspection. They will also review any Field Alert Reports, recalls, or other issues communicated to the District Office. Additionally, many investigators will review results of inspections for other manufacturing sites in other locations or Districts for your company. For example, if a Warning Letter was issued at one of your sister sites, the investigator will likely review the issues noted and the company response to determine if follow-up at your site is needed. Don’t assume that the investigator merely walks into your facility “cold.” They will likely be very aware of your compliance position and have a list of potential concerns or issues that they will examine during their time on-site.
2. What is the motivation or driving factor for the typical FDA investigator? Are they looking to make a name for themselves to advance their own career or is it something else? I think most individuals in industry assume that FDA investigators advance their careers based on the number of FDA-483 citations they provide. This is not the case. Most good investigators are motivated by their desire to ensure the safety of the consuming public. They are concerned with any cGMP violations, but especially those that could harm a consumer. Their primary focus is whether our products are acceptable as measured by their safety, purity, effectiveness, labeled strength, and labeled identity. In short, they are most concerned with product quality. They may cite more minor cGMP violations on a FDA-483 form, but their primary interest is to ensure that we perform in an overall manner that will prevent a negative impact to our consuming public. Sure, there are some investigators that are looking for ways to enhance their own standing within the agency, but more investigators are intent on serving the public by ensuring we do what we should and what we said in our regulatory filings.
3. Is it really possible to influence the outcome of the FDA investigation by how the investigation team manages the investigation? The answer to this question is a clear and definitive “Yes!” I have seen many inspections turn positive or negative simply by how they were managed. When the investigator develops a trust in the management team, feels that the team is open and honest, and believes that the information provided is accurate, the inspection will almost always be more collaborative, positive, and productive. When the investigator feels the company’s inspection team is deceptive (trying to hide something), manipulative (screening out negative information), or hindering the inspection (by preventing access to information or facilities), the inspection almost always turns negative. In fact, when the investigator believes any of these is the case, they can now take even more aggressive action that is supported by more recent regulations. So, be open, be honest, work diligently to share everything requested, and seek to demonstrate integrity in managing the inspection. I know of one situation in which the firm was told directly by the District Office Compliance Officer that a Warning Letter would not be issued merely because the District believed in the integrity of the Quality leadership at the site. Yes, integrity does matter!
4. What does the FDA investigator do with all the documentation they collect? Most of the mountains of documentation collected during an inspection is destroyed after the inspection is closed by the District Office. So, what purpose does it serve? There are really three purposes for the documentation collected during an inspection:
   • To allow further study of potential compliance concerns during the time between on-site visits during a multi-day inspection
   • To document compliance (or non-compliance) activities noted during the inspection (e.g., proof of concerns noted in any potential FDA-483 observations)
   • To facilitate the final report after the inspection (Establishment Inspection Report or EIR)
5. What does the FDA investigator do between leaving your facility for the day and arrival the next at your door? Most investigators spend some time reviewing their observations for the day before arriving the next day. If they are traveling to your site, it is not uncommon for investigators to spend much of their evenings reviewing documentation, making notes about potential concerns, and preparing for their reviews the next day. In many cases, the investigator is communicating with their supervisor or Compliance Office about findings and the direction of the inspection for coming days. It is the rare investigator that does no preparation before arriving the next day.
6. Would you rather have a highly experienced and knowledgeable investigator inspect your facility or one that is less experienced and less knowledgeable? Why? Personally, I would rather have an experienced and knowledgeable investigator inspect my site. These investigators can more accurately and quickly focus on potential issues, their experience allows them to better understand what we do and why, and they tend to need less background information to grasp the concepts of more complex operations and activities. And, these investigators are less prone to citing less significant issues. However, because of their experience, they are more likely to quickly identify more significant issues that could evade a less experienced investigator. So, depending upon your situation, there are advantages to either. Nonetheless, we have no choice in who inspects our facilities, so this is something we have little ability to influence.
7. How have FDA inspections and investigators changed over the last 40 years? Many years ago, FDA investigators all covered many different regulated industries, such as pharmaceuticals, medical devices, food, blood, medicated feeds, etc. They had to learn the regulations and have adequate knowledge of all of these to properly function. Today, they tend to be experts in one industry. For example, now, investigators tend to focus on pharmaceuticals or medical devices or foods. Thus, they have the opportunity to learn about varying packaging techniques, dosage forms, manufacturing techniques, etc. in a way that allows greater depth of expertise. Additionally, FDA tends to recruit more individuals with advanced degrees or industry experience. FDA training programs also provide more in-depth knowledge than 40 years ago. So, on the whole, FDA investigators today tend to have more knowledge about their specific areas of expertise than the investigators of the past that had to have more breadth. As a result, investigations today are more focused and directed. For example, investigations often focus on specific systems. So, an investigator that has just inspected other firms have a solid basis of comparison to assess whether we are fulfilling “current” expectations.
8. What causes an FDA investigator to lose sleep at night and why? FDA investigators take their responsibilities very seriously! The thing that concerns them most is failing to detect GXP violations that ultimately result in safety or health concerns. They never want to be personally responsible for missing a potentially serious issue during an inspection. Thus, you can see why most are so diligent in focusing on issues that most clearly could harm consumers (e.g., data integrity, sterility, foreign contamination, labeling, dosing, etc.).
9. Why do we see so many different approaches taken by FDA investigators (e.g., some want to be collaborative; some are aggressive; some use inspection guides; some merely follow the flow; etc.)? Though FDA inspection guidelines are pretty specific in what investigators should consider examining during an inspection, they do not remove the ability of investigators to use their individual talents to conduct investigations. As a result, some focus on procedures, some on data, some on checklists, some on manufacturing, etc. And, the individual personality of the investigator will often determine the flow and collaboration of the inspection. Typically, the investigator is patient and collaborative as long as you provide information openly and efficiently. I have witnessed a few investigators that are not so patient and collaborative, no matter how the inspection is managed. In these cases, you must remain professional, calm, and continue working efficiently. You must not allow that rare rude or impulsive investigator to intimidate you into mistakes or misstatements.
10. What is the goal of the typical FDA investigator? For them, what constitutes a successful inspection? Most investigators are just like us… they have a job to do and simply want to get it done thoroughly and completely. They are not normally trying to do more than that. We must realize, though, the gravity of their job which is to protect the ultimate consumer of our products. We should attempt, as much as possible, to help them accomplish that task, yet without exposing more information than is requested. Realizing their goal can help us manage the inspection and how we interact with the investigator.

Hopefully, this post has helped you understand better the typical FDA inspection and the inspection approach. When we better understand what is really occurring, we can better manage the flow and content of the inspection.

Have a great day!

(If there are questions that you have about FDA or global regulatory inspections not covered here, please feel free to contact me at henson333@hotmail.com. I will try to help you get your answer directly or through a future edition of The Porch.)

They say that having a dog will bring you many of the very best days of your life… and one of the worst. I tend to agree with this statement. Our family has had several dachshunds over the last three decades and each one has brought much joy to our lives.

Our current dog, Chloe (see photo), has been, perhaps, the most enjoyable of them all. Chloe has a simple life: she eats (this includes both normal meals and food that drops on the floor or that she can steal from our grandchildren), sleeps, and “protects” us from the very friendly black labrador retriever that lives next door. That’s it… nothing more complex than that. When you compare her life to ours, you’ll note that she is not really worried about life’s complexities. She just deals with the day she has the best she can.

I recently watched a movie on a flight called, “A Dog’s Purpose.” The movie is not very deep or critically acclaimed, yet I did enjoy it. Essentially, the story covers several lives of a dog. You see it living on a farm in one life, as a police dog in another, a show dog in another, etc. Eventually, it makes it back to its original owner. However, the theme of the movie is to learn the real purpose of a dog. At the end, there are 5 purposes identified. In many ways, these 5 purposes of a dog could serve us well in keeping our lives focused and fulfilling. Let’s take a look at each:

1. Have fun – A dog’s primary purpose is to have fun and ensure that everyone else has fun, too… at least in its early years. Too many people have lost this. We are so caught up in our daily routine, meeting the expectations of others, and fighting the good fight that we forget to do something fun, at least occasionally. Doing something purposeful to have fun can help keep us grounded, balanced, and mentally cleansed. How about it? Are you putting your responsibilities on “pause” occasionally to do something that has as its only purpose for you to have fun?
2. Save someone else if you can – In the movie, the dog saved his master both physically and emotionally. He found that part of his purpose was to identify the need of his master and work to make that part better. We should endeavor to do the same. Everyone has a need in their life. It is easy to become consumed by our own needs, but exhibit the best of ourselves when we are serving others. Serving others ALWAYS takes the focus off our own problems.
3. Not get caught up in regrets from the past – The past is often a heavy burden. It can weigh us down, drains us, and deceive us. We can’t do anything to change the past and, besides, we probably did what we thought was best at the time anyway. Someone once said, “Don’t let the past use up too much of today.” This is so true. We must focus on the only day we are promised… today. My dog, Chloe, never lets past mistakes carryover to today. A good lesson for us all.
4. Finding someone to share life with – Dogs are social animals. My dog wants to be with me wherever I am. She greets me first thing in the morning and is on my lap when I go to the bedroom at night. She enjoys people and interacts in a friendly way with everyone. Life is not meant to be lived in isolation. We need to intentionally reach out to others. It is tempting to say “no” when invited to spend time with friends or colleagues (who doesn’t enjoy an occasional night just sitting on the couch and watching TV), but we need to interact, network, and befriend others. Life is much better when shared.
5. Just be here now – A dog always gives 100% right now. It is not distracted by devices, upcoming activities, or problems. Its only focus is on what is occurring at this minute. We could probably use more of this attitude. I remember several occasions when I was at a fun event (e.g., golf, baseball game, birthday party, etc.), but was mentally involved in something else. I was not giving my full attention to the activity or people I was with. We need to be more like our canine friends… give 100% to what you are doing right now.

Chloe just turned ten years old… rather old for a dachshund. I know that one of the worst days of my life is coming someday. Yet, there are things about her life now that can be beneficial to me. I am certainly an old dog, but, hopefully, there are things I can still learn and ways I can change to be a better person. Perhaps, you might find yourself in the same position today.

Have a great, productive, and happy day! You never know when a day might be your best yet.

 

There are no words that can adequately express the importance of the Mothers in our life. Not only do they bring us into the world, but they teach us how to survive and thrive under every circumstance, how to treat others, and how to make a difference to the world around us.

I would not be what I am today without the love, nurturing, care, and words of both my Mother and my wife. They both have impacted many lives. So, today, in honor of them and all Mothers everywhere, I thought I would share just a few of their quotes that are most meaningful:

Words from my Mother

• “You can be or do anything in the world… that you are willing to work for.”
• “All I ask is that you do the very best you are capable of doing.”
• “You can learn all you will ever need to know about being a father and husband by watching your father.”
• “Always stand up for yourself and for what is right.”

Words from my Wife

• “You spend 18 years trying to learn how to be a good mother and just when you almost have it figured out, your job is done.” (She didn’t realize at the time that the job is never over.)
• “Some day, your youngest child will go to sleep in your lap for the last time before they grow out of it. Most people might not think about it, but a mother does.”
• “There are some things in our family that we might compromise on, but whenever we possibly can, we’ll all have dinner together around our own table.”
• “No matter what happens, we’ll figure it out and it will be OK.”

So, today, I pay tribute to both of these important women.

And, to my wife of nearly 42 years, our kids have been blessed beyond measure to have you as their Mom. Thanks for all you have done and continue to do for our three kids and seven grandchildren. I love this journey we are on together. You are amazing!

So, do something special for the Mothers in your life today. Cherish each day you have them, especially this day set aside especially in their honor.

I live in the St. Louis, Missouri, area. In the last week, we have been inundated with rain and flooding has devastated many communities. However, there is a funny phenomenon that occurs when one individual talks to another in this metropolitan area. “Well, how much rain did you have? We had ten inches.” The next person invariably will say, “Yes, it has been bad. My rain gauge said we had almost eleven inches.” If there was a third person in the conversation, surely, they would have had twelve inches. When the conversation reaches the limit, the final person will say something like, “We didn’t have that much, but I think my rain gauge is broken.”

We have it built into our nature to “one up” the next person. We want to win. I remember a conversation among three old timers about their dogs. The first said, “My dog is the best tracking dog in the county. There has never been a trail he couldn’t find or hold.” The second said, “My dog is so good that he can follow a trail down the middle of the concrete county highway.” But, the third guy took the cake with his comment, “My dog once followed a trail for three miles that was over three years old.” In essence, in these conversations, the first liar doesn’t have a chance.

Which brings me to what we can learn from this. First, we need to recognize that it is the rare person that will not seek a way to “one up” the story. Sometimes, this occurs in the work setting with something like, “Yes, your team did a nice job getting that project started. But, we should be thankful that my team was able to take that start and drive it across the finish line.” Just be aware that this will occur.

Second, recognizing this tendency, we need to be careful that we don’t perpetuate this. Knowing that this occurs, do what you can to fend it off. Catch yourself when you start your “one up” strategy. Bring the conversation back to the facts, at least those you can verify, and guard what you say. Give credit when it is due and challenge only when it is necessary. I once worked with a person that would ALWAYS try to outdo everyone in every conversation. If you had a product, he had a better one or more than one. If you knew Elvis Presley, he lived next door to him and stood up with him at his wedding. We liked to catch him in these stories by challenging him when it became too outrageous. But, mostly, the best strategy is to simply let it go, if possible.

Finally, knowing that “one upmanship” occurs nearly every single day, the most important learning is to… not be the first liar. In other words, open these conversations in a way that doesn’t promote escalation. For example, instead of saying, “Wow, we received over ten inches of rain in the last two weeks.” Start by saying, “Wow, it has been extremely wet. I don’t think I’ve ever seen it rain so much in two weeks in my life.” This keeps it from becoming a competitive conversation. In the work setting, you can be creating by opening with something like, “When our two teams can tackle a problem together, we can get an amazing result, can’t we?” Do what you can to keep the conversation focused on the facts, but direct the discussion to the positive results, rather than pit one group competitively with another.

So, just be aware… you can eliminate the temptation to “one up” each other totally by making collaborative, general statements rather than setting up the conversation for competitive escalation.

Have a great day! Do something to make the world a better place for someone else today.

Everyone wants to realize a successful career, have a happy family, and enjoy the good things of life. Many are blessed to have all three of these. However, the sad fact is that many do not. Henry David Thoreau once said, “The mass of men lead lives of quiet desperation.” Many do not achieve complete success in life and, as they look back on their lives, admit that the reason can probably be traced to one or more key decisions.

Our lives are measured not by the company we keep, but by the decisions we make. A decision is, in effect, an exchange. We trade one thing or path for another. We give up one thing we can readily grasp within our hands for something completely different. We shift from one direction to a completely different one. We forfeit one thing that is replaced by a new thing. Decisions… exchanges… define our lives.

So, what are those key decisions we make in our lives that define us? Is it really possible to understand what those key decisions might be even before we come face-to-face with them? Can we really decide to decide? My belief is that there is always hope that we can change for the better. Even when we’ve blown it in the past, we can still reverse ourselves and make a better future life for ourselves and others.

Putting together a list of great exchanges we can make is both a risk and a challenge. Can you boil a successful life down to even 10 basic decisions in life? That is the challenge. However, if you even fail to try to create a vision for a successful life, you take the risk that you might be the reason someone failed. Despite that, here is my list:

Ten key exchanges (decisions) we can make that will lead to a better, more successful, more fulfilling life:

1. Exchanging the ordinary for the excellent – There comes a day in life when you must decide whether you will be one that accepts the ordinary or mediocre versus the better choice of excellence. Doing things right. Doing them the right way. Giving your best in every situation. Giving your all. These things don’t easily come nor do they come automatically. They come by choice. There is a conscious decision to be made that shifts us away from the easy road to the better road. Make that choice.
2. Exchanging a focus on self for service to others – There seems to be an epidemic of narcissism in today’s world. Individuals are consumed by what will make them happy… what will be best for them… what can make them the most successful. However, there is a better way. A better choice is to exchange your life for one that serves others… that seeks to make a difference first for those around us. Spending each day striving first to serve others yields a more satisfying and, in my opinion, a more successful one. When you demonstrate a willingness to serve others, you automatically become a leader or one that others seek to emulate and follow. Becoming a better leader and a better person will enhance your life.
3. Exchanging the recognition of others for the creation of value – Recognition is important in a world infused with social media. In an age of “selfies”, followers, and “likes”, individuals are consumed with how much love they get from the world. However, this creates no real value to anyone. A better choice is to seek ways to make a real difference in the world, not seek the adoration of an indifferent set of digital friends. Adding value will bring a sense of accomplishment that recognition could never provide. Deciding to be a doer makes the world around you a better place… and you a happier, more content person.
4. Exchanging blame for accountability in what we do – Why do so few people accept responsibility for their own actions, decisions, and efforts? When did our society become one in which the greatest accomplishment seems to be the attainment of “celebrity victim.” Being a victim serves no one. Accepting accountability for your own actions does. Choosing to be accountable, rather than one seeking to blame automatically puts you in a better place… for everyone.
5. Exchanging fear for adventure – Many individuals get into a rut and are glad to stay there. After all, there is safety in the rut. We know where it is and what can go wrong. However, we miss out on a lot of life when we stay in that rut. A failure to take an occasional, reasoned risk robs us of fun, adventure, and opportunity. Choosing to be a warrior, not a worrier, can bring joy, satisfaction, and adventure that the rut could never offer.
6. Exchanging a love of work for a love for life – Let’s face it, work can bring much satisfaction and fulfillment. It can provide for our own identity and our desired lifestyle. However, just like anything else, out-of-balance focus on work can lead to the detriment of all other areas of our lives. An excessive love of work can cost us much, including our families. Achieving that balance of work and life is an important decision we must all make. And, don’t fool yourself… it is a choice. Don’t lose your family for a title, money, or prestige. It is not worth it!
7. Exchanging rebellion for compliance – I have observed many individuals that simply cannot keep a job or move from one thing to another without focus or aim. In many cases (not all), individuals that are unable to submit to authority (e.g., those that default to rebellion) struggle with working for others. Making the choice to submit, when needed – to follow the rules, to seek to comply with the basic rules of life – fare much better in life. Compliant individuals tend to achieve more success, as well. Certainly, there are times when we need to take a stand, but choosing compliance over overt rebellion is the better choice.
8. Exchanging convenience for commitment – Many individuals have difficulty making and keeping a commitment. For example, marriage was originally designed to be a lifetime commitment. Most wedding ceremonies still use the phrase “till death do us part” in the vows exchanged. However, the divorce rates are still around 50%. Challenges with commitment are evident in other parts of our society, as well. Too many individuals choose convenience over commitment. However, when you choose to be a committed person, you are more likely to have stability in life and be seen as a person with integrity. Commitment is a choice… and one that puts us on a more satisfying and successful life path.
9. Exchanging a reliance upon emotions for a reliance upon facts – As humans, it is easy to allow our emotions to dictate our actions. We react to the events in our life using our gut, intuition, or feelings. However, these emotions tend to taint reality. Failing to pause long enough to consider the true facts can deceive us. It is good to be emotional at times, but we need to ensure that we always utilize facts. For example, being able to step back and ask tough questions can keep us on track. Good questions might include, “Will this really matter? What is the real impact of this? How can I solve this both short- and long-term?” Choosing to allow emotions to drive our actions without consider the facts will almost certainly lead us to poor outcomes in life and work.
10. Exchanging lies and deception for hope and encouragement – Our world is an ongoing challenge every day. This is especially true when we consider our hope for the future. The world will try to deceive us by saying, “There is no God. There is no life after death. There is no hope after life is over.” These are lies! There is a God in heaven that loves us and wants to offer us hope for our eternal future. Exchanging these lies for the hope and encouragement that God offers through His Son Jesus Christ is our only hope (see What is your hope? for more). In my life, the greatest exchange was the decision to accept this gift from God. Exchanging a life lived by my own standards for one based in the love and grace of my Father was the best decision I ever made.

There you have it! Outlined are the ten key exchanges or decisions that can make our lives productive, fulfilling, and meaningful for ourselves and those in our lives. These decisions can impact our work, our family, our friends, and our future. They can dictate whether we live with optimism and hope or fear and despair.

Take an honest look at your life against these key decisions. Have you already made the wrong choices? It is never too late to make a mid-course correction. It is never too late to change course. Even late in life, you can alter your legacy by the decisions you make today. Finally, consider whether you have made that greatest exchange… that one that determines your eternal destiny.

Have a great day!