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Howard T Cooper
President, EQACT,INC
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.
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Upcoming Training
The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process.
Live Session  Wednesday, September 24, 2014 11:30 AM PDT | 02:30 PM EDT,  Duration:90
Recorded Training
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 Access recorded sessions for multiple participants unlimited viewing for 6 months.

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 Access recorded sessions for multiple participants unlimited viewing for 6 months.

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 Access recorded sessions for multiple participants unlimited viewing for 6 months.

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 Access recorded sessions for multiple participants unlimited viewing for 6 months.

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 Access recorded sessions for multiple participants unlimited viewing for 6 months.

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 Access recorded sessions for multiple participants unlimited viewing for 6 months.

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 Access recorded sessions for multiple participants unlimited viewing for 6 months.