Character is that which defines who we really are.  It is our true heart.  Despite what we might say or try to portray, the truth lies imbedded in our character.  Discussions on character have occurred 62 times on The Porch.  It is utterly important for every aspect of our personal- and work-lives.  Below is a list of those prior discussions with a link to the actual posting.  I hope that you might be encouraged and motivated by the content you find here.

We each have the power to make a difference to someone each day. Let’s find a way to make this a better day for someone that crosses our path.

Wisdom from Winnie the Pooh (Wisdom from Winnie the Pooh)

Wisdom from Ralph Waldo Emerson: Our attitude might predict our success (Wisdom from Ralph Waldo Emerson: Our Attitude Might Predict Our Success)

One definition of character: How high do you bounce? (One Definition of Character: How High do you Bounce?)

Get on the bus? (Get on the Bus!)

Wisdom for us from Children’s books (Wisdom for us from Children’s Books)

Things I will not regret (Things I will not regret)

Learning to mind your own business (Learning to mind your own business)

Wisdom of Eleanor Roosevelt (The Wisdom of Eleanor Roosevelt)

Persistence: See the job through… to the end! (Persistence: See the job through… to the end!)

Wisdom from Benjamin Franklin (Wisdom from Benjamin Franklin)

Your life can change in a moment! (Your life can change in a moment!)

Even the undertaker will be sorry (Even the undertaker will be sorry)

Influence without integrity will doom even the best teams (Influence without Integrity will doom even the best teams)

Influence without integrity leads to forced compliance and limited achievement (Influence without integrity leads to forced compliance and limited achievement)

Character trumps reputation, every time (Character trumps reputation, every time)

Characteristics of an excellent life (Characteristics of an Excellent Life(

How we treat others matters (How we treat others matters)

Who is the star and why is it important? (Who is the star and why is it important?)

The Virtue Continuum (The Virtue Continuum)

The value of your signature (The value of your signature)

Our responsibility as a role model (Our responsibility as a role model)

All in… (All in….)

A “berry” nice day! (A “berry” nice day!)

Courage without composure (Courage without composure)

Remembering why we do what we do (Remembering why we do what we do)

Rest, if you must, but don’t quit! (Rest, if you must, but don’t you quit!)

Baseball week at the Porch: Persistence (Baseball Week at The Porch: Persistence)

Integrity matters (Integrity Matters)

Service matters (Service Matters)

What values define you? (What values define you?)

We are all just one step away from stupid: How do you want to be remembered? (We are all just one step away from stupid: How do you want to be remembered?)

Do as I say… not as I do (Do as I say… not as I do)

Our capacity for good (Our capacity for good)

$4 if you argue… ($4 if you argue…)

Things that are not impressive (Things that are not impressive)

Be BIG in the little things (Be BIG in the little things)

Good character (Good Character)

Why do some people go out of their way to help others? (Why do some people go out of their way to help others?)

Turning “spin” into “truth” (Turning “Spin” into “Truth”)

What makes others trust you? (What makes others trust you?)

Watch those doing it right (Watch those doing it right)

Let your light shine (Let your light shine)

The gift of compassion (The gift of compassion)

The gift of abundance (The gift of abundance)

The gift of integrity (The gift of integrity)

We all have a choice (We all have a choice)

The gift of responsibility (The gift of responsibility)

Times when the end does NOT justify the means (Times when the end does NOT justify the means)

Why we still “Remember the Alamo” (Why we still “Remember the Alamo”)

Teaching character (Teaching character)

The value of serving others (The value of serving others)

Is it right; is it fair; is it honest? (Is it right; is it fair; is it honest?)

The discipline of gratitude (The discipline of gratitude)

I believe what you say… (I believe what you say…)

Two essential questions (Two essential questions)

Man-to-man… what our female colleagues need from us! (Man-to-man… what our female colleagues need from us!)

Can you be trusted? How do you know? (Can you be trusted? How do you know?)

The world’s worse excuse-maker (The world’s worst excuse-maker)

When anger gets the best of you (When anger gets the best of you)

Who needs a “narrative” when you can just as easily tell the truth? (Who needs a “narrative” when you can just as easily tell the truth?)

The definition of a great life (The definition of a great life)

My father died exactly twenty-five years ago today.  There have been few days over this past quarter century that I haven’t thought of him.  I was extremely fortunate to have him in my life for those first thirty-seven years.  I truly wish I could have had my father in my life even until now, but I am thankful for the time we had.

Having had a wonderful father gives me pause because I know many individuals that either never knew their father or had him in their lives for even fewer years that I did.  A father plays such an important part of our lives… ways that we might even realize.  When I think of my own father, I am reminded of five key ways he impacted my life:

1. He was a great role model – Much of what I know in life I learned from my Dad… not by what he said, but by what he did.  By his actions, I learned how to be kind, how to care for others, and how to be a good husband and father.  He showed me what it means to live with honor in the workplace and how to see the good in people. Whether he knew it or not, the life he modeled for me showed me what kind of man I wanted to be.
2. He was a terrific teacher – Though I have had dozens of teachers in my life, none was better than my Dad.  He taught me the value of hard work, what it means to be accountable for my actions, and to make good, well-reasoned decisions.  He taught me to do what I said I would do and fulfill my commitments.  I learned much from him that I would likely not have never learned from anyone else.
3. He was a source of unconditional love and acceptance – I was blessed to have parents that loved us unconditionally.  Yet, they had high expectations for us.  We had no free passes, simply because they loved us.  Anything less than our best was just not good enough.  I know I am blessed to have had this in my life.
4. He was an amazing provider/protector and made our lives fun – My Dad worked harder than anyone I have ever known.  His work was hot, dirty, and physically demanding.  He worked outside in all kinds of weather – no such thing as a rain-out or snow day for  him! Yet, we always had fun.  We always took time away for a vacation.  My Dad kept us safe, yet gave us freedom to learn by experience.  He provided a perfect balance.
5. He encouraged me to be more that I thought was possible – My Dad believed I was capable of anything.  He taught me that the only limits were self-inflicted.  Though he did not go to college, there was never any doubt that we would find a way for me to go.  He gave me the gift of pragmatic ambition… do what you want in life, but understand that it has to pay the way.

So, I just wanted to reach out to those of you that didn’t have a father in your life in ways that I had.  Whether or not you benefited in life to have a great father, you can still be a source of inspiration and encouragement for others.  You can be the role model to show others how to live and serve others.  You can teach others how to live, thrive, and make their way in life.  You can extend the kind of unconditional love and acceptance that someone else needs.  You can offer wings of protection to someone that feels alone.  Or, you can be an encourager for those that seem to be in a valley.

Today, I’m thankful for my Dad.  I think back to many wonderful memories.  But, lest I find myself stuck in the past, I know I have to look ahead to the impact I can have on others.  As long as I am able, I want to have a positive impact on those in my life.  No matter what lies in our past, we can make a difference for someone by giving of ourselves in the future.  Find a way to encourage someone today.  You never know when your words, touch, or actions might help pull someone out of a challenging time.

For those of you that find that the loss of your father is still too fresh, I urge you to give it time.  Time has a way of turning sadness and regret into happier memories and encouragement.  Eventually, you will look back on your time with your father as the blessing it was.

And, finally, for those of you fortunate enough to still have your parents in your lives, take a moment to call them or write them a note.  You just don’t know what you have in this life until it is gone.  Someday, when you look up from a phone call, they will be gone.  Send them a word of thanks and encouragement today.

Inspections from regulatory agencies can be some of the most stressful periods ever experienced for some individuals and some plants.  After all, these inspections can determine, literally, the future of the site.  A successful pre-approval inspection can mean the difference between prosperity or struggles in many cases.  For more established sites, a successful inspection can strengthen your compliance reputation or help foster a new culture of compliance.  And, a solid inspection can serve as validation of the hard work expended to properly manage compliance enhancement and inherent compliance risks.

Though much has been written about preparing for and managing inspections, I would like to pass along a few perspectives I have gained over the last few years.  These hints might be helpful as you prepare for your next visit:

1. Confidence is a major contributor to successful inspection results – Let’s face it… the end result of most inspections occurs, not because of tremendous management of the inspection, but because the site has prepared, individuals have diligently documented their work, and you have a stellar culture of compliance at the site. When you have prepared well, your inspection management team operates with more confidence.  Investigators are trained to observe for this confidence and look for signs of concern or weakness.  Being able to confidently present site results and a strong GXP compliance position significantly supports a successful inspection result.
2. Managing the logistics of FDA inspections is becoming more and more important – Regulatory investigators are becoming more and more demanding about the speed of producing documents and whether or not the site was completely forthcoming regarding answers to questions.  With the implementation of new FDA Guidance documents, FDA is now more aggressive about what they have access to, how quickly documents are provided, and who and how questions are answered.  Speed is becoming almost as important as accuracy during the actual inspection, though I would choose the latter over the former, if a choice was absolutely essential.
3. Managing the investigator (or team) is essential – Because of the challenges posed by the need for speed and accuracy in producing information , it is becoming even more crucial that you properly manage both the front- and back-rooms during inspections well.  If you have not rehearsed this recently, it might be worth doing so again, especially if you have new individuals involved.  Understanding the mood and demeanor of the investigator is important, as well.  Pay very close attention to body language, expressions, and comments made by the investigator as the inspection progresses.
4. Remain calm and professional despite potential threats or intimidation – I have heard from industry colleagues examples in which an investigator made a number of comments during the inspection about demanding a recall, escalating items to the FDA manager, or even going public with information.  Knowing that the investigator does not have the authority for much of this makes it essential that you remain calm and professional and not lose your focus.  It is possible that an FDA investigator would occasionally use such techniques to get the plant to share information that they would normally not share.  However, remaining calm can help shift the inspection back to a less stressful relationship.
5. Do not be pressed into making unnecessary commitments – You must never make hasty commitments during an inspection without full knowledge and approval from your senior management.  The FDA investigator may attempt to get a verbal commitment from you that they can include in their report.  It is important to always state that you will respond appropriately when needed and after full collaboration with all functions necessary.
6. Focus on the science, adherence to GMPs, and patient safety – You need to remember that the first priority of FDA or other regulatory investigators is to ensure public safety.  With this in mind, you can often produce information that can negate the concerns of the investigator.  When they realize that there is no public safety concern, the level of alarm often immediately diminishes.
7. Thoroughness of your investigation reports remains important – Every investigation involves the review of investigations (OOS, Exceptions, Complaints, etc.).  This is a focus for every investigator.  Thus, you must remain ever diligent in conducting these thoroughly, documenting all your actions completely, and ensuring that the reports tell a full story.
8. You should have a significant team to back you up – Inspections often move into areas outside the responsibility of the inspected site that requires expert assistance.  For example, questions may arise regarding regulatory filings that require assistance from the off-site Regulatory Affairs function.  Or, you may need R&D assistance to answer detailed product questions.  Remember that you must defer to these experts, when necessary.  Attempting to provide answers without proper input can result in issues.  One note of caution, though, is to ensure that you prepare any individuals from outside the site that speaks with the investigators.  Prepare them in advance similarly to how you might prepare a site subject matter expert before bringing them into the inspection.
9. Stay focused to the end – Some regulatory inspections can continue for weeks.  During an extended inspection, your team may become “comfortable” with the investigator and, as a result, let down their guard.  You must be diligent and focused all the way to the end!  I have seen inspections that went very well all the way until the last day when significant issues were raised.   Allowing team members breaks during an extended inspection can help keep them fresh and alert.  Staying focused throughout an extended inspection is a challenge, but you need to remain on-guard and at-the-top-of-your-game all the way to the end.

Most inspections have moments of trial and tribulation.  But, if you remain diligent and focused, you have a greater probability of best representing your site and its GXP performance. Your ability to adequately prepare and foster an ongoing compliance culture now will pay off the next time your site receptionist calls with the exciting news, “Two individuals from the FDA have just arrived.”  Good luck on your next inspection!

 

Today, The Porch includes a listing and links to the 39 posts published, thus far, that deal with career development.  Here you will find discussions on enhancing your own career, tips on dealing with workplace issues, and ways you can influence the work culture in which you best thrive.  You will also find items on teamwork and dealing with challenging bosses.  Hopefully, you will find items that can accelerate your career or, at least, enhance your work experience.

Have a great day!  Remember, this could still be your best day yet!

Becoming a “High Potential” employee (Becoming a “High Potential” Employee)

Six steps to guaranteed career fulfillment (Six Steps to Guaranteed Career Fulfillment)

Common courtesy in the workplace (Common Courtesy in the Workplace)

4 ways to guarantee failure (4 Ways to Guarantee Failure)

The grass just might be greener on the other side (The grass just might be greener on the other side of the fence)

How to ensure an amazing year-end performance review (How to ensure an amazing year-end performance review)

Tips for making excellent hiring decisions (Tips for making excellent hiring decisions)

Nothing cannot happen today (Nothing cannot happen today)

Who gets promoted… and why (Who gets promoted… and why)

What defines our “culture”? (What defines our “culture”?)

Four Principles of Workplace Stewardship (Four Principles of Workplace Stewardship)

The mystery of good communication (The mystery of good communication)

The best and worst of “culture” (The best and worst of “culture”)

A memo isn’t necessarily reality (A memo isn’t necessarily reality)

Baseball week at the Porch: Teamwork (Baseball Week at The Porch: Teamwork)

Baseball week at the Porch: The Basics (Baseball Week on The Porch: The Basics)

The third inning: The aggressive team is often the winning team (The Third Inning: The aggressive team is often the winning team)

The eighth inning: Rally time! (The Eighth Inning: Rally time!)

The ninth inning: “It ain’t over till it’s over” (The Ninth Inning: “It ain’t over till it’s over”)

Boldness – A career accelerator! (Boldness – A Career Accelerator!)

Weed control (Part 1): The importance of strategic thinking (Weed Control (Part 1): The importance of strategic thinking)

Weed control (Part 2): How will I know strategic thinking when I see it? (Weed Control (Part 2): How will I know strategic thinking when I see it?)

Weed control (Part 3): How can you become a strategic thinker? (Weed Control (Part 3): How can you become a strategic thinker?)

Networking “to do” list for today (Networking “To Do” List for Today)

Achieving the proper balance in management of people resources (Achieving the proper balance in management of people resources)

What problem are you trying to solve? (What problem are you trying to solve?)

Career accelerators: advice from those that have been there… and won! (Career accelerators: advice from those that have actually been there… and won!)

Dealing with ambiguity… more or less (Dealing with ambiguity… more or less)

Things that rob work of fun (Things that rob work of fun)

What if every employee was just like you? (What if every employee was just like you?)

Dealing with the incredible shrinking career pyramid (Dealing with the incredible shrinking career pyramid)

What would I do if my boss was a micro-manager (What would I do if my boss was a micro-manager?)

What would I do if I was feeling discouraged about work? (What would I do if I was feeling discouraged about work?)

What would I do if I received a disappointing year-end review? (What would I do if I received a disappointing year-end review?)

Writing your own next chapter (Writing your own next chapter)

How to tell your boss, “You’re wrong!” (How to tell your boss, “You’re wrong!”)

What it really means to give 100% (What it really means to give 100%)

Staying motivated even when you’ve already blown your goals for the year (Staying motivated even when you’ve already blown your goals for the year)

What successful executives would tell you about your own career journey (What successful executives would tell you about your own career journey )

 

 

Since beginning The Porch, there have been 325 different postings covering a variety of topics.  I have been asked more than once if there is a listing, by topic, that might help one looking for help in a specific area.  Today, I have provided a list of all postings covering topics on leadership.  Much has been said and written about leading well and learning to be a great leader.  Hopefully, you might find something in these postings that would help you advance your own abilities and skills in this critical area.  Shown below are the names of the specific postings on The Porch and a link to view the content.

Have a great day!

Time to swap shoes (Time to Swap Shoes)

Competence without compassion (Competence without Compassion)

Results without relationships (Results without Relationships)

Mark Twain on people and getting things done (Mark Twain on People and Getting Things Done)

John F. Kennedy on leadership, opportunity, and action (John F. Kennedy on Leadership, Opportunity, and Action)

Who would you follow? (Who would you follow?)

Is there a mouse on your team? (Is there a mouse on your team?)

Respect and appreciation as leadership values (Respect and appreciation as leadership values)

Do others know how much you care? (Do others know how much you care?)

The best team doesn’t always have the most talent (The best team doesn’t always have the most talent)

Expectations without encouragement lead to a lack of motivation (Expectations without Encouragement lead to a lack of motivation)

Passion without principles (Passion without Principles)

Servant leadership: show how much you care (Servant leadership: showing how much you care)

Valuing the opinions of others (Valuing the opinions of others)

Investing in the careers of others (Investing in the careers of others)

Leaders create more leaders (Leaders create more leaders)

Support without strategy… not good (Support without strategy… not good)

Lessons on leadership from the Conductor (Lessons on leadership from the Conductor)

Adding value to the lives of others (Adding value to the lives of others)

Baseball week at the Porch: Coaching (Baseball Week at The Porch: Coaching)

The first inning: Everyone has a chance (The First Inning: Everyone has a chance)

The fifth inning: Many singles are better than one solo home run (The Fifth Inning: Many singles are better than one solo home run)

The sixth inning: A strong bullpen is key (The Sixth Inning: A strong bullpen is key)

Tribute to great leaders (Tribute to great leaders)

Three simple steps for successfully managing people (Three simple steps for successfully managing people)

Conflicting signals and how they impact our culture (Conflicting signals and how they impact our culture)

Lollipop moments (Lollipop Moments)

Inspiration for leaders (Inspiration for leaders)

The beginning… or the end? (The beginning… or the end?)

Leading with heart (Leading with heart)

The right person doing the right job (The right person doing the right job)

The ONE thing that separates a great leader from an ordinary one (The ONE thing that separates a great leader from an ordinary one)

A simple lesson in employee engagement (A simple lesson in employee engagement)

Minds, hearts, and hands: creating a culture of engagement (Minds, Hearts, and Hands: Creating a culture of engagement)

You can change someone’s day (You can change someone’s day)

10 mistakes that can doom the success of any leader (10 mistakes that can doom the success of any leader)