David Hanlon – Preparing for FDA Inspections

David Hanlon has had a long and impressive career in the pharmaceutical industry. He has helped various manufacturing sites prepare to meet FDA Compliances. FDA inspections can be disruptive, because most of the time they are unannounced (exception with clinical trial sites and sponsors of clinical investigations). However, they are necessary and if not handled correctly, can impact a business success on many levels. Good preparation and management of the inspection can make the experience less upsetting to the day-to-day business activities.

An adverse consequence from a failed inspection can really harm a company and can range from time cost due to responses to regulatory observations and delayed product launch, to publicly announced Warning Letters or even civil or even criminal litigation by the FDA. Proper preparation can prevent unnecessary harmful consequences.

The FDA conducts inspections for a myriad of reasons including; a routinely scheduled surveillance inspection; a preapproval inspection to decide a products approval; and a “for cause” inspection arising from a product complaint, recall, or information given to the FDA by a whistleblower.

The purpose behind each inspection no matter what the catalyst is to determine if violations of FDA laws are occurring, and if so, try to have the involved entity voluntarily corrected issue without further action.

He has more than 20 years of experience performing manufacturing site transfers and new product scale-up and introduction for sales of over $750+ million annually. He also supervised and had direct involvement in over 100 FDA, European and health agency inspections.

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Requirements of a Project Manager

David Hanlon is a stellar leader who has many years of experience as a project manager in the pharmaceutical field. He has overseen the development of new products and managed technology transfers. Project managers are extremely important to the success of any pharmaceutical manufacturing operation.

The competitive nature of the industry makes it imperative for a pharmaceutical or biotechnology company to place successful products on the marketplace. Putting a knowledgeable project manager at the helm of the operation is an integral part of that strategy. There are many challenges involved in creating new pharmaceuticals or other medical products. The drug development processes can incur many pitfalls from development delays, planning problems, unforeseen mistakes, cost overruns, and losses due to high turnover.

Many shortcomings in the launch process can be avoided with a good project manager at the helm. A product manager differs from a general manager in that they only deal with the operation and running of the company, as well as manufacturing, marketing, sales, human resources, and financial planning.

A project is temporary and organized to achieve a certain objective or goal, with teams assigned for that particular project and strict deadlines in place. Project managers are needed to manage clinical trials, implement marketing programs, launch blockbuster drugs, run sales meetings, and in the development process.

David Hanlon is involved in every capacity of the product launch and pays great attention to detail and makes sure that the job runs smoothly. He holds a strong work ethic and believes in following each project until completion, assuring that there are no loose ends.

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David Hanlon – Trends in Pharmaceutical Products

David Hanlon is one of the leading professionals in the pharmaceutical industry. In his current position he oversees the integration of a 1 billion dollar endo-vascular and cardio-vascular device business. Part of his job is to stay on the forefront of the pharmaceutical industry. In 2015, there are a few trends setting the tone for “big pharmas” future. Many of these innovations come in the wake of rising healthcare and poor patient follow-up.

Personalized health distributed and tracked in a smart phone society. Apple released its iHealth app for the iPhone, which is a toolbox for healthcare technology companies to create their own health-based apps. The new Apple app should start to take off this year, and lead to a steady stream of competing apps at the iTunes app store.

The dramatic annual growth in global healthcare spending is forcing governments to find ways to bring rising healthcare costs down. New innovations and technology are one way that costs are being kept down. Many of these innovations will involve giving patients hi-tech, wearable devices and apps, which can help doctors stay in better contact with patients and on a more regular basis.

David Hanlon serves as a both a leader and a manager within his current role at Cardinal Health. He has also overseen the design of new facilities that manufacture Pharmaceutical products such as creams, liquids, ointments, sterile needles, tablets, as well as medical device products. Through his efforts, the company has seen much success.

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David Hanlon – Fuse by Cardinal Health

Presently David Hanlon is the Senior Vice President of Quality and Regulatory Affairs for Medical Devices at Cardinal Health.  The $103 billion healthcare services company is headquartered in Dublin, Ohio, and is works to improve the cost-effectiveness of health care. Cardinal Health allows hospitals, pharmacies, ambulatory surgery centers, laboratories and physician offices to reduce costs and improve the quality of care by being able to focus on patient care instead.

Cardinal Health opened Fuse, an innovative lab focused on improving the future of the health industry. The lab focuses on ways to reduce healthcare complexity and expense by optimizing operations. Fuse also makes the clinical data side of operations more streamlined so that each patient can get the right treatments in a timely manner.

Cardinal Health is an important link in the health care supply chain, providing medical products, pharmaceuticals and services to more than 100,000 locations every day.  It’s also leading the industry in direct-to-home medical supplies distribution. The company is a leading manufacturer of surgical products such as surgical apparel, gloves, and fluid management products. Cardinal Health is ranked #26 on the Fortune 500 and operates the largest network of radio pharmacies in the nation, each one dispensing life saving early diagnosis products.

David Hanlon has held other top positions in the healthcare industry such as Vice President for Wyeth, which is now part of Pfizer and Fisher Diagnostics. He oversees a group of highly-trained personnel in areas including product management, relationship building, strategizing company’s growth, upholding strong ethics and overseeing product launch.

 

David Hanlon – Social Skills in Business

David Hanlon is a businessman and a leader in the pharmaceutical field. He understands that one of the keys to success in this field is the ability to build relationships with those around him. He is the Senior Vice President of Quality Assurance and Regulatory Affairs. His job is to oversee multiple manufacturing sites, work with the pharmaceutical scientists, and deal with customer concerns. Therefore, he needs to be able to interact and build rapport with a variety of personalities. This is a skill that every successful businessman has.

It is important for a businessman or woman to have a good education in their field. They should know the ins and outs of the business world, and have a specialized knowledge of the industry their company is in. Most importantly though, they should have excellent people and social skills. Working in business requires you to be able to manage others, and to work well on a team. It is essential that you are able to build trusting relationships with your colleagues in each department. If you are not able to communicate with the people in other departments, your business could crumble quickly.

It is absolutely vital that any business person be able to quickly build rapport and trust with potential clients. If a potential client does not see that you, and your business, are trustworthy and have their best interest in mind, then they will go to a competitor. Once you have gained clients, you should be able to maintain good relationships with them. If you do this, they will remain long standing, loyal clients.

David Hanlon has excellent social skills and works hard to keep his customers and is employees happy.

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David Hanlon – What is Quality Assurance and Regulatory Affairs in Pharmaceuticals?

David Hanlon has built a career in Quality Assurance and Regulatory Affairs in pharmaceutical manufacturing. He specifically works in medical devices and diagnostics. This is one of the most important jobs for a pharmaceutical manufacturing company because it ensures that each manufactured product is pure and safe. There are a myriad of control measures and health regulations, which each product needs to meet. The Senior Vice President of Quality and Regulatory Affairs makes sure that each manufacturing site complies with all safety measures and that each product is properly identified and safe.

Maintaining the quality and the regulatory affairs of a product is an endeavor with many facets. It is essential for the person in charge to create a well-planned strategic roadmap for quality and regulatory organization structure. Pharmaceutical companies often have multiple manufacturing sites and multiple projects. Therefore the man or woman in charge of overseeing quality assurance and regulatory affairs must be organized, and able to keep track of each individual site. The best way to do this, is to create an overall strategic road map and apply the same strategies to each site.

Each site must also be compliant with the U.S Food and Drug Administration (FDA). The person in charge needs to be well versed in all of the health and safety regulations, so that they can ensure that each site is following the proper procedures and regulations. This department of the pharmaceutical company ensures that their manufacturing sites are following national and international regulations, and are producing high quality products. David Hanlon is highly skilled at maintaining his manufacturing sites and always makes sure they are following all of the necessary regulations.

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David Hanlon – Why is Research and Development Important?

David Hanlon is a hard working Senior Vice President, who places a lot of emphasis and importance on research and development. Research and development drive scientific innovation. It is a body of work that is directed towards the introduction, innovation, and improvement of products and processes. A research and development team is especially important in the pharmaceutical world because they are the ones who create new products and medicines.

However, research and development is costly to companies due to regulators increasing the number of required clinical trials. Despite the cost, it is still vital to fund a healthy research and development team. The pharmaceutical field is competitive, and without a strong research and development team, a pharmaceutical company will quickly fail and a new company will take its place.

Pharmaceutical research is responsible for creating treatments, vaccines, and cures. These products help millions of people who are afflicted with illnesses. They treat diseases that were once untreatable, and keep large populations of people from contracting various viruses. Pharmaceutical research is essential to public health and scientific advancement. When new drugs and treatments are released to the public, the health of the public as well as the economy is boosted. This is because the workforce is healthier, and access to new medications causes the cost of other medications to decrease.

All of these factors are evidence of the fact that pharmaceutical research and development is worth the investment. Cutting edge research will help a company stay secure long term, and will offer the public fantastic new treatments. David Hanlon works with the research and development team in his company often, and understands the importance of a strong research team.

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David Hanlon – Advancing a Career Through Education

Even though David Hanlon was immersed in his career, he decided to take the time to earn a Master of Business Administration from Shenandoah University. He also has a Bachelor’s Degree in Chemistry and Biology from Westmar University, and a Bachelor of Science in Business Management and Systems Personnel from Buena Vista College. After he graduated from college, he began building a strong career in pharmaceutical manufacturing, however, he understood that in order to progress his career even further, he would need a Master’s Degree.

A Master of Business Administration Degree is useful to anyone working in the business world. If you aspire to hold a high powered position within a company, you will need the skills and education that are available through these programs. The core courses involve accounting, finance, marketing, human resources, and operations methods that are most relevant to management strategy and analysis. All of these items are vital aspects for running a business, and if you hope to be positioned high within management, you will need a working knowledge of each of these.

This knowledge will allow you to work cross-functionally throughout the company. It will also give you the skills you need to manage various teams on different projects.

This degree will teach you how to approach management using a scientific methodology. In order to be successful as a manager, it is important that you plan out your actions and always react in a suitable manner. You need to understand the people you are managing, and you need to know how to encourage people to perform well on every project that they are a part of.

David Hanlon uses his MBA to enhance his management skills and his knowledge of the business world.