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Parenteral Drug Association Connecting People, Science and Regulation ®

Developing a Microbial Monitoring Plan and Leveraging New Technologies for Effective Sterility Assurance in Aseptic Processes - New Course

Oct 19 - Oct 19, 2018 |
Oct 19, 2018 |
Bethesda North Marriott Hotel & Conference Center | North Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

A strong microbial monitoring plan and a leveraging/introduction of new technologies should be used for all sterile medicinal products and sterile active substances. As required by the principles of Quality Risk Management, this ensures that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product.

The course provide tools, rationales and guidelines for designing a strong cleanroom microbial monitoring plan and for leveraging/introducing new technologies for effective sterility assurance in aseptic processes.

Specific topics include:

  • FDA and EU GMPs requirements for total particle and microbial environmental monitoring for aseptic processes
  • Design of an environmental monitoring plan based on risk assessment and process analysis
  • New technologies and instruments for environmental monitoring: feature, scientific description and benefits
  • New technologies and instruments for environmental monitoring implementation: FDA and EU GMP requirements and implementation/validation steps

Who Should Attend

To be determined

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

  • Design a microbial monitoring plan for an effective sterility assurance in aseptic processes
  • Explain the implementation of new technologies for an effective sterility assurance in aseptic processes



On or before September 3, 2018

After September 3, 2018


On or before September 3, 2018

After September 3, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 18, 2018, 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.

General Course Information

Please arrive at the 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852 USA


For more information, please contact:

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

Gilberto Dalmaso, Senior Advisor and Pharma Customer Advisory Team Manager, Life Sciences Division, Particle Measuring Systems

Gilberto has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. In 2006, Gilberto Dalmaso was awarded an Honorary PhD in Pharmaceutical Microbiology from Università degli Studi di Milano in recognition of his innovative microbiological scientific studies and new technologies introduced to the pharmaceutical industry. Today he is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States. Dr. Dalmaso is the Global Consultant and Subject Matters Experts Team Manager for Particle Measuring Systems. In this role and with his team of subject matters experts, 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.

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 #542 | ACPE #0116-0000-18-004-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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