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Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process

Oct 22, 2020
Washington, DC

  • Education
  • The Americas

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Overview

This training course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes. Participants will learn to formulate a strategy to proactively look for areas of potential microbial contamination and minimize activities or processes that may cause risk.

Specific activities will include:

  • Reviewing how microbiological quality may be impacted in steps throughout the manufacturing process
  • Identifying risk assessment tools, including the Failure Modes and Affects Analysis (FMEA) approach
  • Creating an example FMEA, incorporating process steps that may have microbial contamination risk
  • Using the FMEA approach to evaluate process and behavior

For more options and/or related training courses, please visit the page(s) below.

PDA Annual Pharmaceutical Microbiology Conference Training Course Series

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Peter Noverini
Peter Noverini
Baxter Healthcare Corporation

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify the aspects of pharmaceutical manufacturing which may affect microbiological quality
    2. Develop an FMEA, quantifying risk for individual process steps
    3. Quantitatively evaluate steps within a process
    4. Develop ways to reduce or minimize activities that may increase microbial contamination risk
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in microbiological risk assessments.

    Departments Engineering, Facilities, Manufacturing, Quality Assurance, Quality Control, Research and Development, Training, Validation Roles Analyst, Consultant, Engineer, Manager, Microbiologist, Scientist, Specialist, Supervisor

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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.

Grand Hyatt Washington

1000 H St NW
Washington, DC

  • Accommodations

    The PDA room block is not currently open. Please check back April 1, 2020.

  • Amenities

    N/A

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001.

Self-Parking: $42 per day
Valet Parking: $62 per day

Other Options

Metro – The Hotel lobby is connected to the Metro Center (Blue line) Metro Station.

Directions

Registration Fees

Early Registration
Registration Type Price By September 7, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979
Regular Registration
Registration Type Price After September 7, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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.

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 [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Sep 22, 2020, no fee will be charged. After Sep 22, 2020, 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 by Sep 22, 2020, a full refund will be given minus a $200 fee. After Sep 22, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
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