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.
David Hanlon - Pharmaceutical Manufacturing
David Hanlon is a professional in the pharmaceutical industry with more than thirty-five years of progressive management experience. He has had Global responsibilities and overseen multiple sites, handling areas such as; pharmaceutical manufacturing, regulatory/QA & compliance, and R & D, as well as medical device experience in manufacturing.
The pharmaceutical drug manufacturing process involves the industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process is normally broken down into a few different units operations, such as milling, granulation, coating and tablet pressing.
The formulation process is a very extensive p-art of manufacturing. Before a drug can be manufactured a group a formulation development scientists must evaluate its stability, uniformity, and many other factors. After the drug is evaluated, a solution must be developed to deliver the drug in its prospective form such as liquid, solid, semi-solid, tablet, controlled release, capsule, and other variations.
The next phase is the milling process, which is necessary to reduce the median particle size in a drug powder. The main reasons for this process are to increase homogeneity and dosage uniformity, increase solubility and bioavailability.
Granulation is another important step and is the opposite of milling. Granulation is done for many reasons such as preventing the "demixing" of components in the mixture. This helps improve the flow of powders and improves the ability for a tablet to form.
David Hanlon has worked in all areas of manufacturing including quality assurance and compliance; research and development; and the sales and marketing of new products.
David Hanlon - Processes for Technology Transfer
David Hanlon has spent numerous years aiding in the transferring of technology to various pharmaceutical manufacturing sites. He makes sure that every detail is covered during the transfer and that there are no loose ends. A technology transfer in this particular case means that a pharmaceutical company wants to move from their existing manufacturing site to a new manufacturing site. It can also mean that there is to involve the move between two process trains or even from one facility to another.
In pharmaceuticals, there is usually more than one manufacturing building on a single campus, so a transfer if technology can just be from one building to another building. Many times, a technology transfer is when there will be a switch from one manufacturer to someone else’s manufacturing site.
The first step of a transfer must be to go over the raw materials and Active Pharmaceutical Ingredient and make sure that it’s the same and are coming from the same supplier. Then the original manufacturer’s information such as raw materials and process parameters must be studied. The performing equipment must also be compared and finally the comparison to SUPAC guidelines.
Meeting Scale-Up and Post-Approval Change guidelines are the last steps to finalizing a technology transfer. The FDA guidelines are set online and identify the types of equipment. Usually, there will be fewer issues if most of the equipment falls within the same size, class, and sub-class.
David Hanlon good eye for detail allows for extensive tracking and recording. He works to keep each team cohesive and focused, which makes each move flawless.
David Hanlon - Research and Product Development
David Hanlon is an experienced veteran in the Medical Device Research and Development industry. For over 15 years he has overseen important projects with the company’s he has managed. He stays hands on when it comes to all areas of new products research, as well as product manufacturing and marketing.
Those choosing work as pharmacists in the industry most tackle a variety of areas: research and development, phases of product development, management and operations, sales and marketing, clinical trial research, drug information, regulation, health policy, scientific/professional affairs, and quality control. The industry has been growing extensively throughout the years and new advancements are made daily in product development.
Most companies in the pharmaceutical industry have corporate facilities throughout the country, with a heavier concentration in areas such as New York, Delaware, New Jersey and Pennsylvania, Illinois, Indiana and parts of California. Many biotechnology start-up firms are headquartered in California and sections of the mid-west. Globally the pharmaceuticals market is worth US$300 billion a year, and is expected to rise to US$400 billion within three years. The 10 largest drugs companies control over one-third of this market, some of them having sales of over $10 billion a year.
David Hanlon is a great leader who has played a key role in the development of new medical devices and pharmaceutical products in the health industry. He works side-by-side with scientists and other healthcare professionals to make new products that help people and improves their lives.
David Hanlon - Everything you Need to Know About Cardinal Health
David Hanlon is currently the Senior Vice President of Quality Assurance and Regulatory Affairs for Cardinal Health, and he has held this position since August 2014. Cardinal Health is a healthcare supply chain in North America. They are a Fortune 22 company and deal heavily with pharmaceutical manufacturing.
Cardinal Health is essential to care. They employee nearly 35,000 employees all across the world, and deal in almost every aspect of health care. They help ambulatory surgery centers, pharmacies, physician offices, and hospitals focus on patient care. They ensure that their clients have ways to reduce costs, improve the quality of care, and enhance their efficiency, so that patients get high quality care.
Within their company, they strive to create a cohesive working environment. They believe communication and team work are essential to the health of their company. They believe, that when their employees come together, they can serve their clients better than any other health care supplier. Their values involve having incentive and being adaptable, optimistic, enthusiastic and competitive. Each one of their employees has a tenacious customer commitment, is genuine, open, direct, and respectful. All of their employees are inclusive, and work together with trust and confidence. Most importantly Cardinal Health can be trusted to do the right thing.
This company has a customer-centric focus and works hard to build strong relationships within the company and with customers. Cardinal health is not only a leader, but they employ leaders who are focused on getting the right things done. David Hanlon is one of these leaders. He embodies each one of Cardinal Health’s values and helps provide top of the line health care.
David Hanlon - The Classes of Medical Devices
David Hanlon specializes in the quality assurance and regulatory affairs of medical devices. During his time with Cardinal Health, he has worked with Class I, II, and III Medical Device Products. These are classifications regulated by the U.S Food and Drug Administration (FDA). These classifications are based on the qualities and the risks associated with the device.
The FDA has instituted classifications for approximately 1,700 generic types of devices. They are then grouped into sixteen medical specialties. These specialties are referred to as panels. They are then assigned one of the three regulatory classes, based on the potential effectiveness and the level of safety. The intended use of the device, as well as the indications for use, are also taken into consideration during class assignment. The class in which the device is assigned, determines what type of premarketing submission or application is required for FDA clearance.
Class I devices are considered low risk products. Therefore there are the least number of regulatory controls surrounding them. Class II devices are a higher risk than Class I. This means that there are more regulations surrounding the manufacture and distributions of these products. The manufacturer needs to be able to provide a reasonable level of assurance regarding the devices effectiveness and safety. The final classification is Class III. These are devices which offer the highest risks, and therefore have the highest level of regulatory control. These products need to be approved by the FDA before they are marketed. David Hanlon has manufactured devices of all classes, and fully understands all of the FDA regulations.
David Hanlon - What Are Clinical Trials?
David Hanlon organizes and oversees multiple clinical trials for the pharmaceutical manufacturing company he works for. Clinical trials are a vital aspect of research and development. They are the bridge between product development and the public market. Clinical trials are a form of research, which ensure the safety of a product, and the effectiveness of a product.
Before a product reaches the clinical trial stage, it first goes through a stringent development process. A scientist will develop a hypothesis related to the effects a new compound can have on the human body, and how it could potentially treat an illness or disease. Then that compound is developed and the testing begins. The first clinical trials are on animals. The scientist observe the animals to see if they have any side effects from the medication. They also record the efficacy of the medication on the disease it is supposed to treat. This stage of testing determines whether the new drug is harmful to a living body or not.
The next stage in a clinical trial is human testing. Once it has been determined that a drug is safe for living creatures, scientists have to test it on humans because animals may react differently to drugs. Clinical trials begin with small groups of patients in order to discover whether or not the new substance is harmful. Once researchers have learned more about the risks and benefits of a drug or treatment, they open the trials to larger groups of people. This is the final test of a clinical trial. Once the scientists have determined that the drug will help improve public health, it is then released to the public.
David Hanlon has years of experience with clinical trials and organizes them for his company on a regular basis.
David Hanlon - The American Association of Pharmaceutical Scientists
David Hanlon is a Senior Vice President with Cardinal Health, a health care supply company. He is also a member of the American Association of Pharmaceutical Engineers (AAPE). This organization as well as other organizations, such as the American Association of Pharmaceutical Scientist (AAPS) are vital to careers in the pharmaceutical industry. It allows access to current research and resources all across the nation.
The AAPS is one of the most popular pharmaceutical organizations, it was formed in 1986, and its headquarters are located in Arlington, Virginia. It offers important resources and connections to all professionals in the pharmaceutical industry.
For anyone hoping to build a successful career in pharmaceuticals, the AAPE is an excellent non-profit organization to join. Approximately ten thousand scientific professionals are members and the group supports interaction, career growth opportunities, and knowledge exchange between its members. It is led by an executive council, which the members elect, and has various focus groups, discussion groups, and functions. According to their main webpage, their mission is to advance “the capacity of pharmaceutical scientists to develop products and therapies that improve global health,” and their core values are learning, innovation, service, inclusiveness, and integrity.
The pharmaceutical field is not only filled with scientists but also businessmen who manufacture the pharmaceutical products and then market them. It is important for every member of this field to have access to current research and peer-reviewed publications. The AAPS not only releases a pharmaceutical research journal, but they also offer electronic courses and webinars to help educate their members.
David Hanlon, like so many of his colleagues, understood the benefits of being connected to so many others in his field. He became a member of a pharmaceutical organization because he knew that the best way to advance his career was to be connected with other scientists and businessmen and have access to their myriad of resources.
