Time: 8:30 a.m. - 4:00 p.m.
This course will enable participants to use and interpret data for particle counters and microbial air samplers in cleanrooms. Topics will include the impact of total particulates and microbial contamination in ISO 5 environments. Participants will also be able to set alert and action levels for total particle and microbial contamination based on collected data, prepare a trend analysis and annual report, and manage out of specifications.
Who Should Attend
Managers in pharmaceutical production, quality assurance, microbiological laboratory, and maintenance and engineering will benefit from taking this course.
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- Create data trends and data interpretation for total particulates in cleanroom air
- Create data trends and data interpretation for total microbial contamination in cleanroom air
- Manage Out of Specifications (OOS)
- Set alert and action levels for total particulate and microbial levels in cleanroom air
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #528 | ACPE #0116-0000-17-004-L04-P | 0.6 CEUs
Type of Activity: Application
Continuing Education for Professional Engineers
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 6 CPC credits.
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 6 PDHs.
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PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Bethesda North Marriott Hotel & Conference Center5701 Marinelli Road
Bethesda, MD , United States
Gilberto Dalmaso, PhD, Global Aseptic Processes Development Manager, Particle Measuring Systems
Dr. Gilberto Dalmaso has over 25 years experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM) that improve quality and process understanding while yielding significant cost savings. In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Aseptic Processes Development Manager for Particle Measuring Systems. In this role, he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes. With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, technologies and methods.