By Alan Horowitz
C-level managers know that the first line of defense when things go wrong in an organization is the people on the front lines. When it comes to pharmaceutical manufacturing, that front line consists of the operators and others on the factory floor.
And, if that front line is poorly trained and lacks the knowledge to know when equipment is not performing well, the entire organization can suffer. Bill Cairns, president of BCM Group, consultants to manufacturers, says, “The person at the machine is in the best position to judge the performance of the equipment, so they better know the equipment.”
The recently established Life Science Institute (www.tlsiseminars.com) of East Stroudsburg, PA, provides training on all facets of pharmaceutical production. It serves not just operators, but engineers, managers, and manufacturing executives who want to better understand their manufacturing processes.
A team of former pharmaceutical executives with years of production experience established the institute. John DeVivo, the institute’s COO, has experience designing, marketing, and selling process equipment used in the life sciences industry and has held senior executive positions with major equipment manufacturers. Paul Cimmino, the institute’s executive director, is experienced with managing manufacturing facilities in the life sciences industry and developing industry training. According to Cimmino, about 66% of the pharmaceutical industry’s manufacturing is located within 150 miles of the institute.
The institute’s faculty includes Tom Chirkot, Ph.D., P.E., who has over 30 years experience in the industry and specializes in blending, mixing, granulation, drying, and NIR (near-infrared) spectroscopy; Lorrence Green, Ph.D., a microbiologist who has taught science and business at various colleges; Sanni Raju, Ph.D., a licensed pharmacist who has spent much of his career in the manufacturing of pharmaceutical and nutriceutical products; and B. Lee Wilson, a chemist by education who has spent much of his 30-plus-year career in the manufacturing of solid dosage forms.
The Importance Of Operator Training
Operator training is vital if a company expects to have well-running, efficient production. The industry faces a chronic shortage of skilled operators, notes Cairns, and turnover tends to be high. In addition, it is a challenge to keep operators up to date with skills related to cleaning, operations, maintenance, adjustments, setup, and running. Equipment vendors, of course, often provide training, but many times, training for new employees and updates to equipment are left to the pharmaceutical manufacturer.
“We’re providing compliance training, which is mandated by the FDA,” notes DeVivo. The training is aimed at the pharmaceutical, dietary supplements, cosmetics, biopharmaceuticals, and food industries, involving both wet and dry production.
The institute’s customized training strategy includes a patent-pending approach. Rather than just lectures, it includes hands-on experience using state-of-the-art equipment. “We can demonstrate, using simulated materials, what people can expect to see in a drug, cosmetic, or food manufacturing facility,” says DeVivo. “We offer an environment where people network, relate to the instructor, and get to have hands-on experience with equipment.”
Classes are limited to 28 students, and the institute is also able to provide training at the client’s site. Training customized to the client’s needs is also available.
Seminars being offered run one or three days. Upcoming seminars include “Truth in Blending!” and “The Manufacture of Tablets & Capsules with a Comprehensive Emphasis on Mixing.” The blending seminar is a one-day class and costs $495. The tablets and capsules seminar runs three days and costs $1,995, which includes meals and two nights at a deluxe hotel.
“We have developed a training methodology that covers all facets of pharmaceutical production,” says Cimmino. “And we employ the same or similar equipment used by our clients in their manufacturing facilities.”