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A System of Leadership for the 21st Century: Lessons from

David Markovitz - President, GMP Training Systems

One hundred years ago, the first federal vitro Diagnostics industries, FDA has regulations affecting the Life Sciences identified seven systems of control. industry were enacted. This was an era They are: Management controls, that saw the United States government Corrective and Preventive action, Design take an active role in protecting the controls, Materials controls, Records, consumer. Both the pharmaceutical Documents, and Change controls, industry and the processed food industry Equipment and Facilities controls, and were new and growing rapidly at the Production and Process controls. birth of the 20th century. In August 2002, the FDA announced The past one hundred years has seen GMP’s for the New Millennium, a tremendous strides in health care and life science and risk-based approach to sciences. Today, innovations and new product quality regulations incorporating ideas are bursting forth faster than ever an integrated quality systems approach. before. Product life cycles are They’ve identified and integrated the shortening. Competition from around following principles into this new the globe is more intense than ever. The initiative: baby boomer generation is aging, and  Risk-based orientation. putting relentless pressure on the life  Science-based policies and sciences industry for solutions, standards. preventions, and cures for all sorts of  Integrated quality systems maladies. orientation.  International cooperation.  Strong Public Health protection. The Pressures to Change This and other new initiatives no doubt The Food and Drug Administration is will put even more pressure on the Life now examining our systems of control Sciences industries to perform at and our systems of management. In increasingly higher standards. It is February of 2002, FDA implemented a becoming more difficult to successfully systems approach to inspections for the lead and manage an enterprise in the life . They have sciences arena. identified six overall systems to be managed effectively. These are: Quality system, Facilities and Looking to the Past Equipment system, Materials system, Production system, Packaging and The answers to sustaining a healthy and labeling system, and the Laboratory thriving enterprise may just lie in our Control system. The FDA makes it clear past. One hundred years ago a that management is responsible for the remarkable man, Theodore Roosevelt, development and upkeep of these held the Presidency. He was President systems. In the Medical Device and In- of the United States from 1901 to 1909.

 Copyright 2005 ALL RIGHTS RESERVED 1 GMP Training Systems www.GMPTrainingSystems.com Theodore Roosevelt, enshrined on Mt. ration consists of only four or five items, Rushmore, is considered by historians to which taken together just meet the be among the top five Presidents in requirements of a strong and healthy terms of effectiveness and leadership. man, the loss of one item is a serious This article examines Roosevelt’s thing. If we had been given canned leadership philosophy and how we can corn-beef we would have been all right, apply his lessons in today’s competitive but instead of this the soldiers were world. issued horrible stuff called ‘canned fresh beef.’ There was no salt in it. At the Roosevelt’s influence was felt long best it was stringy and tasteless; at the before he became President. He was a worst it was nauseating. Not one-fourth State Assemblyman while in of it was ever eaten at all, even when the his early 20’s, served as Civil Service men became very hungry.” Commissioner for two Presidents, was President of the Board of Eight years later Roosevelt occupied the Police Commissioners, Assistant White House when Upton Sinclair wrote Secretary of the Navy, a Colonel in the his landmark book, . United States Army, and Governor of Sinclair’s exposé on the filth and New York. It was in 1898 during the contamination in the meat processing Spanish American War that Roosevelt industry rocked the nation. Roosevelt, got his first inkling that there were being a voracious reader, obtained an problems in the processed food industry. advance copy of Sinclair’s book. One In the spring of 1898, the USS can picture Roosevelt slamming down Maine blew up in Havana harbor. The the book, and shouting, “AHA! Now I United States declared war on Spain. know why that ‘canned fresh beef’ was Roosevelt resigned as Assistant so horrible.” After corresponding with Secretary of the Navy and, along with Sinclair, Roosevelt ordered Secretary of Colonel Leonard Wood, formed the 1st Agriculture James Wilson to get to the US Volunteer Cavalry. The press bottom of this matter. An investigation dubbed them the . After was conducted and a report filed with training near San Antonio, Texas, the the President. Roosevelt used that report Rough Riders took trains to Tampa, to move through Congress the long- Florida, where they embarked on ships stalled and the taking them to Cuba. Once there, Meat Inspection Act. He signed both Roosevelt led the Rough Riders up Acts into law on June 30, 1906. Kettle Hill, then San Juan Hill, thus ending Spanish Rule in North America. Dr. Harvey Wiley was the Chief In 1899, Roosevelt documented his Chemist in the US Department of experiences in a book entitled The Agriculture when the Pure Food and Rough Riders. Drug Act went into effect on January 1, 1907. He thus became the first Describing the voyage from Tampa to Commissioner of what today is called Cuba, Roosevelt said, “The travel rations the Food and Drug Administration. which had been issued to the men for the voyage were not sufficient, because the meat was very bad indeed; and when a

 Copyright 2005 ALL RIGHTS RESERVED 2 GMP Training Systems www.GMPTrainingSystems.com Roosevelt takes Charge knew he could bring the United States onto the world stage. And he also knew As Vice-President in 1901, Roosevelt that doing so would require the support was thrust into the Presidency upon the of the American people. He was likely assassination of President William the first President who used the Press to McKinley. With the country reeling his advantage to get that support. from an anarchist’s action in gunning down the President, Roosevelt was quick Roosevelt felt that a canal through the to visibly assume the mantle of power. isthmus of Panama was critically He was a man of action, and he didn’t important in achieving the aim of world take long to strengthen the power of the power and respect from the world’s Presidency. It was Roosevelt who leading nations. First, it would reduce coined the phrase, “,” which the cost of shipping goods from coast to is still in use today. He believed coast, and second, and most important to strongly in leading by example. He Roosevelt, was that it would enable the knew that, especially as President, US Navy to move between the two great people would watch him to see if his oceans with greater dispatch. In his actions were consistent with his words. quest to get the canal built, he This authenticity helped him achieve encountered many critics and adversaries everything he was able to accomplish as within Congress. After leaving office, the 26th President of the United States. he said in 1911, “I am interested in the because I started it. If I Leadership, as embodied by Theodore had followed conventional, conservative Roosevelt, is a system. There are methods, I should have submitted a several parts to how he led and dignified paper to the Congress, and the managed; yet they are closely woven debate would have been going on yet, together as a system. It is difficult to but I took the canal zone and let examine any single element of his Congress debate, and while the debate leadership method without seeing how it goes on the Canal does too.” needs the other elements present to make it succeed. Yet, to learn from this great When Roosevelt took office in 1901, the leader, we’ll examine separately those was the fifth largest elements that comprise the Roosevelt in the world. For Roosevelt, this System of Leadership wouldn’t do. A leading power must have a large Navy, and he pressed Congress to fund a Navy that was Creating and Communicating a second only to Great Britain by the time Vision his term as President ended in 1909. He sent the entire fleet, sixteen

dubbed the , around Roosevelt had a vision that the United the world to call in every major port of States become a leading world power. the world. This voyage sent a The country in 1901 was still recovering resounding message to the entire world from the Civil War. The United States that the United States was now a force to was not recognized as a leading world be reckoned with. power by the leading powers of the day, mainly European nations. Roosevelt

 Copyright 2005 ALL RIGHTS RESERVED 3 GMP Training Systems www.GMPTrainingSystems.com Lesson Number One – Create and that he alone didn’t have the military Communicate a Vision experience to accomplish this. He arranged for Col. Leonard Wood, an Develop a vision for your company, accomplished military man, to take your division, or your department. charge, and Roosevelt assisted him as Lt. Those people working in your enterprise Colonel. He knew that he did not have should know exactly what it is they’re the military competence at that point, being asked to achieve. An effective having only served in the New York leader will not only develop a clear state militia. But he also knew that he vision, but also communicate that vision had a capability to communicate to everyone clearly. Posting a memo or effectively with this diverse group of sending a broadcast e-mail message is men. So together, Col. Wood and NOT an effective means of Roosevelt were unstoppable. They communicating a vision. One must do earned the trust and respect of their men. something big, something dramatic, to get people’s attention. And the message Roosevelt was a man of his word. In must be repeated over and over again. 1904, he was elected President in his In just about every speech he delivered own right, in a huge landslide victory. throughout his Presidency, Roosevelt After his election he stated that he would reminded the citizens of his vision for not run again in 1908. He cited the fact the country. It was his relentless pursuit, that he had been President for all but six his zealous drive, which caused people months of his first term, and that he to support him. would respect the precedent set by and only serve two terms. Four years later, after thoroughly Generating and sustaining trust enjoying the job as President, he regretted making the statement limiting Trust and integrity were critically himself to two terms. But he lived by important to Roosevelt’s success those words and did not seek the throughout his career. People will trust nomination in 1908. That’s called you if you prove that you are competent. integrity. People will trust you if you care about them. People will trust you if you give Lesson Number Two - Generating and them the opportunity to speak up and sustaining trust among those you are raise differing points of view, and then leading listen. People expect their leaders to be When Roosevelt assembled the Rough competent. So the first element here is Riders in 1898, he assembled a diverse to gain the competence to do the job. band of eastern intellectuals, his friends This may require hard work. Roosevelt from his days at Harvard, Western once said “I have never won anything roughnecks from his days in the Dakota without hard labor and the exercise of territories, athletes (a champion polo good judgment and careful planning and player), writers, ranch hands, Native working long in advance.” Americans, and others. He developed them into a crack Cavalry unit. He knew

 Copyright 2005 ALL RIGHTS RESERVED 4 GMP Training Systems www.GMPTrainingSystems.com Congruity is important here as well. neighborhood children, as he wore Your actions should match your words. glasses beginning at a very young age. Ethical and honest behavior can be As he entered his teens, his father contagious. Leaders set the tone for challenged him to build his body and those they are leading. This is especially bought athletic equipment to help him important in the highly competitive achieve a stronger body to accompany business world we confront today. his robust mind. In his twenties, as he tried his hand at ranching in the Dakota Competency, congruity, integrity, and territories, he was called “Dude” and trust are also critical when it comes to “Four-eyes” by the rough and tough building effective teams. Building an cowboys out west. It was from these effective team takes time and takes some experiences early in life that Roosevelt nurturing. This nurturing process helps developed the courage to overcome fear in achieving a shared commitment to the and move forward even in dark times. vision as well. Building an effective team often means hiring people more Lesson Three - Conveying hope and talented than you. optimism

Conveying hope and optimism In these times of worldwide economic and political pressures, people do Upon becoming President, Roosevelt respond positively when the leader inherited a country that was rife with conveys hope and optimism. The old disputes between Labor and Capital (Big adage, “Is the cup half empty or half Business). Monopolies were forming, full?” resonates still today. Those stifling competition. The economy was leaders who take the half-full approach stagnant. Shortly after becoming and convey that approach to those President, he said, “I preach the gospel around them tend to fare better during of hope. Our nation is one among all the the tough times. nations of the earth which holds in its hands the fate of the coming years. We A leader has the responsibility to get enjoy exceptional advantages, and are people in the proper frame of mind, to menaced by exceptional dangers, and all get psyched up, to move forward. A signs indicate that we shall either fail leader who sees good ahead will have greatly or succeed greatly. Here is the more followers than one that wallows in task, and I have got to do it.” despair. Communicating a positive message, particularly in tough times, Roosevelt was always looking to the must be repeated over and over. The future. He believed in America’s optimistic outlook is contagious. optimistic dream. But he also knew that achieving greatness meant working hard Tough times may require that the vision and overcoming fear. Growing up was a be adjusted, or modified. An effective challenge for Roosevelt, as he had vision should be achievable given the asthma, and a weak, sickly body. existing resources and conditions. Roosevelt struggled to keep up with all Otherwise, the optimistic look ahead the physical activities of youth, and was may just be perceived as unattainable, even called “Four-eyes” by the thus causing people to go through the

 Copyright 2005 ALL RIGHTS RESERVED 5 GMP Training Systems www.GMPTrainingSystems.com motions, and not really supporting and Taking action, taking calculated working toward achieving the aim. risks, and having a sense of adventure Focus and alignment on achieving the vision is important. Consider the Roosevelt was a man of action. He liked following diagram. The big arrow can facts and wanted to see for himself. In represent the vision of your company, 1980’s management literature, the term your division, or your department. The “management by walking around” was smaller arrows within the big arrow can popularized. Theodore Roosevelt represent different divisions within the practiced that a good eighty years before company, different departments within it became the latest “management fad”. the division, or different people within a He was the first President to visit a department. Which organization, A or foreign country while President, when he B, do you think will move forward went to Panama to check on the progress faster? of the Panama Canal.

A

B

A leader’s job is achieving the alignment Roosevelt said, “Life is a great displayed by Figure B above. This adventure, and you cannot win the great requires constant communication and prizes unless you are willing to run attention. certain risks, unless you are willing to pay certain penalties.” Roosevelt did take great risks, but they were always calculated risks. He used fearlessness

 Copyright 2005 ALL RIGHTS RESERVED 6 GMP Training Systems www.GMPTrainingSystems.com not as recklessness, but with a calculated certain point action must be taken. We eye. He understood the risks and don’t always, if ever, have the luxury of possible penalties before he embarked waiting for all the facts to be in, for all on an initiative. He also said, “Be the confirmation, for all the study group practical as well as generous in your results to be in, before taking action. ideals. Keep your eyes on the stars, but Achieving great accomplishments remember to keep your feet on the requires a certain degree of risk. The ground.” winners are those who can sort through all the data and pick out the relevant He saw the great value of air power for facts that indicate whether success is the military, and awarded the Wright achievable. Winners also have the Brothers the first contract for aircraft for capacity to overcome obstacles that get the Army. He was criticized by his in the way of progress. political foes for this folly. Looking back 100 years later, we can see that he was right. Optimizing your System of Leadership After being out of the White House for four years, he felt that his successor, As we now face FDA’s System , had betrayed him Approach to Inspections of our facilities by not continuing several of his policies, and the GMP’s for the New Millennium, particularly in the area of the it behooves us to examine and optimize conservation of natural resources. He our System of Leadership. campaigned for the Republican nomination in 1912, but Taft had by this Taking heed of Roosevelt’s Four time maneuvered his loyalists into the Lessons for Effective Leadership can key party positions. Taft’s political help you become a better leader and a operatives wouldn’t seat Roosevelt’s better manager yourself. Examine how delegates at the convention. Rather than this system of leadership and acknowledge defeat, Roosevelt formed management can be integrated into your the Progressive Party, better known as personal style of leadership. the Bull Moose Party, and ran for President on that ticket. Roosevelt Another important quote from Theodore wasn’t one to let obstacles get in his Roosevelt is, “Success, the real success, way. He always had a back-up plan. does not depend upon the position you Another quote he used frequently is, “It hold but upon how you carry yourself in is hard to fail, but it is worse never to that position.” have tried to succeed.” Throughout his career, Roosevelt always focused on the task at hand. He always Lesson Number Four - Taking action, looked to do his very best in whatever taking calculated risks, and having a position he currently held. He believed sense of adventure that rather than seeking success, a leader should seek to deserve success. Every A bias toward action is a key office he ever held he quite sincerely requirement for an effective leader. believed would be the last he would Planning is necessary, yes, but at a hold.

 Copyright 2005 ALL RIGHTS RESERVED 7 GMP Training Systems www.GMPTrainingSystems.com As the challenges continue to mount in Learn how David can help your reaching the top of your industry, and company achieve higher levels of working to stay at the top, these lessons performance by going to from Theodore Roosevelt can be www.GMPTrainingSystems.com and invaluable. Strive every day to www.TheInnovatorsWay.com. incorporate these lessons into your personal plan and you just might reach David can be reached at 714-289- your personal pinnacle of success. 1233 or at [email protected]

David Markovitz is the President of GMP Training Systems, a consulting and training firm specializing in helping the Life Sciences industries.

David is the author and/or co-author of Becoming the Best: Making Optimization Happen, GMP Makes Good Business Sense, The Team Process Improvement Workbook, The Innovation Resource Handbook, and the 212 Optimization Tips booklet.

David has developed a one-of-a-kind innovative approach to teaching the history of FDA regulations and the leadership and management skills required to maintain compliance. David brings Theodore Roosevelt Back to Life in presentations for the Life Sciences industry.

David is well known for helping pharmaceutical and medical device companies use GMP compliance to improve their overall performance, productivity, and profits. He has over twenty-five years of management experience with SmithKline Beckman, Nutrilite Products, Organon Diagnostics, and a division of Johnson and Johnson.

 Copyright 2005 ALL RIGHTS RESERVED 8 GMP Training Systems www.GMPTrainingSystems.com