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Parenteral Drug Association Connecting People, Science and Regulation ®

Application of Quality by Design and ICH Q9 Rules to Aseptic Processes and Their Impact to Sterility Assurance - New Course

Oct 20 - Oct 20, 2017 |
Oct 20, 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 better use and interpret the ICH Q9 and QbD Guidelines for application in aseptic processes. Participants will learn to design and analyze their aseptic processes while considering the risk points and their management. They will also understand the impact of and possibilities offered by the QbD Guideline to improve their aseptic processes.

Who Should Attend

Managers in pharmaceutical production, quality assurance, microbiological laboratory, and maintenance and engineering will benefit from this course.

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

  • Apply quality by design (QbD) guidelines to aseptic processes
  • Interpret the application of ICH Q9
  • Apply risk management for aseptic processes
  • Design an aseptic process based on QbD



On or before September 4, 2017

After September 4, 2017


On or before September 4, 2017

After September 4, 2017

Government/Health Authority/Academic



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 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.


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


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Paola Lazzeri, GMP Specialist, Particle Measuring Systems

Paola has extensive experience in supporting pharmaceutical companies in contamination control, including cleaning and disinfection strategies. Her experience with pharmaceutical manufacturers goes back to 2005 in a cleanroom contamination control systems dealer company. During these years, she improved her knowledge of pharmaceutical aseptic production and GMP quality processes and gained in-depth experience of GMP areas cleaning and disinfection.

Today, Paola is the GMP specialist for the Sterility Assurance Team at Particle Measuring Systems. In this role, she collaborates and consults with pharmaceutical companies to develop and implement principles to monitor and control microbiological contamination by improving science-based cleaning and disinfection strategies.

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 #452 | ACPE #0116-0000-17-005-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.