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Parenteral Drug Association Connecting People, Science and Regulation ®

Bioburden and Biofilm Management

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 provide scientific understanding and real world practices for the management of bioburden and biofilm in pharmaceutical and biopharmaceutical production processes. Microbial control of pharmaceutical API and biopharmaceutical drug substances or API production processes is a significant quality and compliance problem today.

Major topics include the following:

  • Mechanisms surrounding biofilm formation and the complex interactions that exist between planktonic and sessile modes of microbial contamination
  • Principles and best practices in the design of facilities, utilities, and equipment to minimize bioburden with emphasis on biofilm control
  • Proven practical approaches to preventing bioburden and biofilm using real word examples
  • Typical control levels for various types and stages of biopharmaceutical production including critical utility systems
  • Best current available technology and sampling practices for bioburden and biofilm detection, including trend analysis and decision principles within the quality management system

Best practices for remediation of contaminated processes and equipment will be reviewed with case studies where possible. The case studies will provide lessons learned in effective quality investigations and regulatory interactions once problems occur. This course will present practical approaches to the prevention, detection, and remediation of microbial contaminations that participants can use in daily production and laboratory operations.

Who Should Attend

This course is intended for scientists and technical staff, as well as middle to senior level managers in pharmaceutical and biopharmaceutical quality control, quality assurance, regulatory affairs, or manufacturing and development.

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

  • Discuss the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations
  • Explain the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems
  • Explain the mechanisms surrounding biofilm formation and the complex interactions that exist between planktonic and sessile modes of microbial contamination
  • Provide information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems
  • Discuss principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations
  • Manage microbial quality issues and conduct effective investigations, remediation, and regulatory interactions

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

Marc Mittelman, Principal, Mittelman & Associates, LLC

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 #476 | ACPE #0116-0000-16-051-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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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