PDA to Launch First-of-its-Kind Ethics Course on Pharma Manufacturing

Attendees of PDA Week 2025 in Palm Springs, April 6-11, can look forward to Pharma Manufacturing Code of Ethics – Your Responsibility to the Patient and Your Organization, a first-of-its-kind course.

Last year, PDA looked at the courses offered across our industry by not-for-profits, for-profits and academia on pharmaceutical manufacturing and discovered a clear gap. Nowhere could we identify an in-depth course focused specifically on pharmaceutical manufacturing ethics.

That was puzzling, especially considering many of the most severe GMP-compliance issues identified over the past two decades were caused by a general lack of good ethical decision-making within manufacturing and those areas supporting it.

In principle, our industry has traditionally considered the CGMPs to be the foundation to ensure product quality (SISPQ-safety, identity, strength, purity and quality). What we have not considered is that this belief blindly assumes that good ethical decision-making is present, which is clearly not always the case.

In reality, ethics is the foundation over which CGMPs rest. While poor ethical decision-making may provide an employee, a company or an area within a company short-term benefits (in many cases financial), in the long term, great damage is often done, with the patients, the company and the employees suffering the consequences. Strong pharmaceutical manufacturing operations and the units that support them are built on and sustained through good ethical decision-making.

The two-day PDA Pharma Manufacturing Code of Ethics course is designed to focus on understanding and developing good ethical decision-making skills to help industry professionals and their companies succeed in the long term.

The course includes case study exercises led by former FDA inspectors, a dedicated session focused on better understanding yourself (the process for how we make decisions) and the science of ethical decision-making led by a clinical psychiatrist, small group activities led by industry experts to reinforce the principals discussed, and activities around creating an ethic oath and ethical code specific to pharmaceutical manufacturing.

I really look forward to this exciting new course!