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2019RapidMicro-1988x680

2019 PDA Rapid Microbiological Methods Workshop

Oct 23 - Oct 24, 2019
Rockville, MD

  • Conference
  • Workshop
  • Western Hemisphere Events

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Program Highlights

Important date: Register by Aug. 9 and save!

Overview

The validation, approval, and implementation of rapid and alternative microbiological methods has been steadily increasing within the pharmaceutical, biopharmaceutical, compounding pharmacy, and advanced therapy medicinal products (ATMP, gene and cell therapy) industries. Novel drug products and innovative manufacturing processes now require modern strategies for demonstrating microbiological control.

The 2019 PDA Rapid Microbiological Methods Workshop will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes. Presentations by subject matter experts and global regulators will focus on real-world practices for rapid and alternative microbiology testing of in-process samples and sterile and nonsterile finished product.

Major topics to be covered will include:

  • Regulatory expectations for validation and implementation
  • The impact of the revised Annex 1 on the use of rapid methods
  • How to overcome roadblocks and perceived issues related to the implementation of alternative microbiology assays and instrumentation
  • Recent case studies by industry end users on validation, regulatory submissions, and implementation
  • The detection of microorganisms relevant to manufacturing processes, environmental monitoring, and facility control, including Mycoplasma
  • Current status of compendial chapter in support of rapid methods
  • New paradigms necessary for the acceptance of technologies not based on the colony-forming unit

This Workshop will present practical approaches to rapid microbiology testing that participants can use in daily work, laboratory, and manufacturing operations.

Agenda Coming Soon

Additional Information

  • Learning Objectives

    Learning Objectives

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

    • Understand the benefits of alternative and RMM technologies as compared with classical microbiological methods
    • Comprehend the regulatory environment, current policies, and expectations for validation, submissions, and implementation from FDA, EMA, and other regulatory authorities
    • Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use
  • Who Should Attend

    Who Should Attend

    • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation, Regulatory Affairs, Research and Development, Validation, QP
    • Level of Expertise: Senior Management, Scientists/Technicians
    • Job Function: Supervisor, Researcher, Analyst, Operative Personnel
  • Accreditation

    Accreditation

    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:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
Rockville, MD
Phone: +1 (301) 822-9200

Make a Reservation
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    To make reservations at the Marriott Bethesda North Hotel and Conference Center, please call the Hotel at +1 (301) 822-9200 and reference the PDA Meeting to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6:00 p.m. on the date of arrival otherwise specified on your reservation information.

  • Amenities

    The Marriott Bethesda North Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron, and an ironing board. This hotel has a smoke-free policy and no pets are allowed.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 20 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International, 24 miles away, and Baltimore-Washington International, 34 miles away.

Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75.

By Car

Bethesda North Marriott is located at 5701 Marinelli Road, Rockville, MD 20852.

$15 Self Parking

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price by August 9
Member $1,495
Non-member $1,695
Young Professional Member $748
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310






Regular Registration
Registration Type Price after August 9
Member $1,695
Non-member $1,895
Young Professional Member $848
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310






* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
  • Annette Bacchus
    Manager, Programs
    Tel: +1 (301) 656-5900 ext. 221
    bacchus@pda.org

Exhibition Inquiries
  • David Hall
    Vice President
    Tel: +1 (301) 656-5900 ext. 160
    hall@pda.org

Training Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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