As the Senior Director of Education at the Parenteral Drug Association (PDA), Mike Porter leverages over thirty-three years of extensive experience in regulated environments to enhance educational initiatives within the pharmaceutical and medical device sectors. His role is pivotal in supporting the FDA grant aimed...
As the Senior Director of Education at the Parenteral Drug Association (PDA), Mike Porter leverages over thirty-three years of extensive experience in regulated environments to enhance educational initiatives within the pharmaceutical and medical device sectors. His role is pivotal in supporting the FDA grant aimed at advancing education and outreach to the 503B compounding community, a critical area in ensuring the safety and efficacy of compounded sterile preparations. Mike's expertise in risk management, quality assurance, and compliance with regulations such as 21 CFR Part 11 and ISO 14971 positions him as a key figure in driving educational programs that address the unique challenges faced by compounding facilities.
Under his leadership, PDA is developing comprehensive training modules that focus on best practices in aseptic processing, biopharmaceuticals, and design control. These initiatives not only aim to elevate the standards of compounding practices but also empower technical staff and frontline workers through targeted coaching and development. Mike's proven track record in managing diverse teams and fostering a culture of continuous improvement is instrumental in ensuring that these educational efforts translate into tangible benefits for the industry.
By integrating his extensive knowledge of Good Laboratory Practices (GLP) and Computer System Validation into PDA's educational framework, Mike is committed to enhancing the operational capabilities of the 503B compounding community. His vision is to create a robust educational ecosystem that not only meets regulatory requirements but also promotes innovation and excellence in pharmaceutical manufacturing and operations. Through these initiatives, Mike Porter is not only shaping the future of compounding practices but also reinforcing PDA's role as a leader in advancing the pharmaceutical industry’s educational landscape.