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Parenteral Drug Association Connecting People, Science and Regulation ®

How to Use and Interpret Data for Particle Counters and Microbial Air Samplers - New Course

Oct 19 - Oct 19, 2017 |
Oct 19, 2017 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Education
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Duration:  1 day
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.

Upon completion of this course, you will be able to:
  • 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

Standard

Member

On or before September 4, 2017
$1,169

After September 4, 2017
$1,299

Nonmember

On or before September 4, 2017
$1,403

After September 4, 2017
$1,559


Government/Health Authority/Academic

Member

$779

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 19, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Class Schedule

All courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

This course will take place at:

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852 USA
Phone: +1 (301) 822-9200

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

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.

Continuing Education for Pharmacists

ACPE 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

New Jersey

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.

North Carolina

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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