Howard T Cooper
President
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.

His experience includes:
  • Designing and implementing Quality Systems from scratch in several startup operations.
  • Managing both single and multiple site quality operations
  • Assisted in revamping failing quality systems under warning letters and consent decrees
  • Advised large FDA regulated companies to improve their quality operations.
Upcoming Webinar
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Recorded Webinar
Establishing a Reduced Testing Process for Incoming Materials
The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process.
Recorded Session Get life time access for one participant with download option!

Boundaries, Scope, and Major Elements of Medical Device Quality
This webinar will start with product development and then moves forward discussing the many cross-functional activities in this complex product lifecycle. The first focus is on the product and then designing it to meet customer requirements. The focus then shifts to developing the quality system that maintains the product and then uses the system to improve both the product and the process. Although Part 820 will be the dominant emphasis, frequent references will be made to ISO 13485 as well as ISO 9001.
Recorded Session Get life time access for one participant with download option!

Establishing a Reduced Testing Process for Incoming Materials
The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process.
Recorded Session Get life time access for one participant with download option!

Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Recorded Session Get life time access for one participant with download option!

Mapping the ICH Q10 Quality System to ICH Q7A, Active Pharmaceutical Ingredients GMP and Part 210-211, Final Dosage GMP
The FDA and other regulatory bodies have attempted to define quality activities, roles, and responsibilities since regulation began. As you know, compliance describes the minimum level of quality required to maintain a state of control. Compliance has focused on documentation of quality activities and less on user/patient needs and requirements. Granted, regulation is needed to help overcome the inertia of human behavior.
Recorded Session Get life time access for one participant with download option!

The ICH Q10 Quality Manual
One of, if not the first document requests made by FDA, other regulatory bodies, or an external auditor is the index to the Quality Manual (QM). The Quality Manual Index (QMI) provides a quick overview of not only the organization of the quality system but also the relationships between multi functions. But perhaps, the most important objective of the QM is that it demonstrates that the company does or does not understand basic quality principles and really understands how inter-functional departments communicate and collaborate in decision-making that is so important to satisfying customer needs and requirements.
Recorded Session Get life time access for one participant with download option!

Comparing the Pharmaceutical and Medical Device Lifecycles
This webinar will explain the workings of the product lifecycle for pharmaceuticals and medical devices. Although the goal of product lifecycle is to yield a product meeting user and customer requirements, the product lifecycle differs between pharmaceuticals and medical devices because of the nature the products and their intended use.
Recorded Session Get life time access for one participant with download option!

Developing the Quality System from Scratch
The opportunity to design a quality system from scratch offers great rewards in experiencing and understanding the functions of quality systems. For me, this "dream" of building the "perfect quality system" began during my early quality management days as I learned and experienced quality system successes and failures. I learned from these thinking and dreaming, "If only I could set up my own quality system".
Recorded Session Get life time access for one participant with download option!

3-hr Virtual Seminar: Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Recorded Session Get life time access for one participant with download option!

Designing And Implementing The Quality System From Scratch
The opportunity to establish a new quality system from scratch has three potential results. The most rewarding is a cross-functional systems approach that balances quality activities to achieve product performance requirements and meeting internal and external customer requirements (needs & wants). The least desired outcome is a failed quality system that is so dysfunctional that it threatens the organization’s very existence.
Recorded Session Get life time access for one participant with download option!

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