By Paul Thomas, Managing EditorTwenty-six of the Food and Drug Administrations top guns the Agencys most experienced drug investigators are now in the midst of a year-long training program. Once trained, they will lead the most difficult, high-risk manufacturing plant GMP inspections. They are the new Pharmaceutical Inspectorate (PI), or, in civil servant speak, Level III Drug Investigators.In synch with its 21st century GMPs, FDA is reinventing its entire field inspection program to make it leaner and savvier. Instead of rule-based compliance and equal opportunity oversight, inspectors will now be guided by scientific principles, prioritizing inspections based on processes and operations that pose the greatest potential risk to consumers.FDA expects the new Inspectorate to be the vanguard of this brave new regulatory era, helping to spread the gospel of quality systems, risk assessment and advanced science and engineering throughout the ranks of drug investigators. Is it up to the task?Im more optimistic right now that FDA is moving in the right direction than Ive been in years, says Jim Akers, president of the consulting firm Akers Kennedy and Associates (Kansas City, Mo.). The key people are saying all the right things. Akers, who has done some training for FDA in the past, believes that none of the Agencys initiatives will matter if the core concepts dont trickle down into the field, and this is where the Inspectorate comes in. What were talking about is one of the key infrastructure elements that needs to work, he says.There will be challenges, though, Akers says. First, its no secret that the science and engineering expertise of the investigation cadre needs upgrading. The PI training will help, but perhaps not enough. Its also no secret that the Agency has faced a chronic brain drain, as many of its most qualified inspectors have bolted to higher-paying consulting or industry positions. The PI title could make the most elite investigators even more attractive outside the Agency.This is a great, great thing FDA has done, says Michael Anisfeld, president of Globepharm, Inc., a regulatory consulting and training firm in Deerfield, Ill. Theyve finally recognized that their inspectors need more expertise.Like Akers, Anisfeld isnt so sure the PI can have an immediate impact. Ive been to several of the presentations where FDA has talked about the curriculum, and it all seems good, he says. But when Ive talked to several FDA inspectors, including supervisory managers, theyre basically ignorant of whats going on. It hasnt trickled down to the field yet.The training is designed to address these issues and others. While the Level III investigators will be managed and given site assignments by the Office of Regulatory Affairs in the field, the training has been a collaborative effort on the part of ORA, the Center for Drug Evaluation and Research (CDER) including Ajaz Hussein and key members of the Office of Pharmaceutical Science other FDA Centers, industry and academia. In addition, it follows on the heels of stepped up training programs for investigators in medical devices and food.The Pharmaceutical Inspectorate is expected to meet several needs at once:
- to satisfy congressional and industry demands for a stronger, tighter regulatory process;
- to enhance integration and collaboration between the Agencys drug review and evaluation processes, between field offices and the Centers, and between the Agency and industry in general;
- to help address the current backlog of drug investigations and stay on top of what the Agency deems are the most critical manufacturing facilities needing a watchful eye.
|THE PHARMACEUTICAL INSPECTORATE CURRICULUM|
The following curriculum outlines the training for the Pharmaceutical Inspectorate. Trainees will visit FDA headquarters in Rockville for just three week-long sessions over the course of a year to complete the seven modules.
The first session, which took place last August, covered the first three modules. The second session, in late January and early February of this year, tackled Modules 4 and 5, while the last session, later this spring, will be devoted to the final two modules.
Following the three sessions, trainees will be assessed for additional wants and needs, then return to Rockville in the fall to spend time from one week to more than one month, depending on the individual in close contact with experts in the Centers in order to reinforce lessons learned in training and fill in knowledge gaps investigators may still have.
A certification board comprising Center experts, experienced field investigators and others will then review the candidates for certification. The exact means of final evaluation have yet to be determined, but will likely include written tests and performance audits.