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Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods

Dec 07 - Dec 08, 2017 |
Dec 08, 2017 |
PDA Training & Research Institute | Bethesda, MD
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

The control of microorganisms in our manufacturing processes and environments is one of the most important tasks in ensuring products are safe and effective. This is true for conventional pharmaceuticals, biotech products, compounding pharmacy drugs, gene and cell therapy products and radiopharmaceuticals. However, conventional microbiology methods are antiquated and do not support the need for faster, accurate and reproducible results. Therefore, the modern laboratory should develop innovative approaches for the detection, quantification and identification of microorganisms using alternative and rapid microbiological methods (RMM).

This comprehensive training course is designed to provide an intensive review of currently available RMM technologies, validation strategies, applications for use, global regulatory views and validation expectations, financial justification models, and technology identification and implementation plans.

The most recent guidance documents on how to validate RMMs, including PDA Technical Report No. 33, USP chapter 1223 and Ph. Eur. chapter 5.1.6 will be discussed in great detail. Additionally, strategies on how to use statistical methods when comparing a new RMM with the compendia method will also be presented, as this is now a regulatory expectation when a firm is seeking approval to use the new method. Case studies on meeting validation and equivalency criteria will also be presented.

Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

Who Should Attend

  • Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/process development
  • Microbiology, Quality Control, Quality Assurance, Manufacturing, Validation, Regulatory Affairs, R&D, Discovery, Finance
  • Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors

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

  • Discuss the benefits of alternative and RMM technologies as compared with classical microbiological methods
  • Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classical microbiology procedures
  • Identify technologies that will be compatible with your products, test samples and required time to result
  • Explain current regulatory viewpoints, policies and expectations for RMM validation, submissions and implementation
  • Develop business plans and return on investment justifications
  • Apply industry best practices for validating new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ strategies
  • Utilize statistical methods to demonstrate equivalence between an alternative method and the compendia method

Standard

Member

On or before October 23, 2017
$1,709

After October 23, 2017
$1,899

Nonmember

On or before October 23, 2017
$2,051

After October 23, 2017
$2,279


Government/Health Authority/Academic

Member

$1,139

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by November 7, 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 lecture 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:

PDA Training & Research Institute
4350 East West Highway
Suite 150
Bethesda, MD 20814
Tel: +1 (301) 656-5900

Contact

For more information, please contact:

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

Michael J. Miller, PhD, President, Microbiology Consultants, 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 #481 | ACPE #0116-0000-17-023-L04-P | 1.2 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 12 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 12 PDHs.

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https://store.pda.org/Meetings/Login.aspx?ID=3789

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