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Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process

Oct 22, 2020
Washington, DC

  • Education
  • The Americas
Cancelled

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 Quality Control/Analytical Training Courses
PDA Annual Global Conference on Pharmaceutical Microbiology Training Courses

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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
Bio
Peter Noverini
Baxter Healthcare Corporation
Peter Noverini has 20 years of experience in the parenteral drug and medical device industries, specializing in environmental monitoring, bioburden evaluation, microorganism characterization, and validation of sterilization processes, as well as supporting analysis and implementation of alternate / rapid microbiological methods (A/RMMs). Additionally, he has participated on PDA Technical Report TR13 “Fundamentals of an Environmental Monitoring Program" and TR69 “Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations."

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

    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

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

    A block of rooms have been reserved for meeting participants at the Grand Hyatt Washington. The rate is $299 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 21, 2020. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    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 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

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

The Hotel lobby is connected to the Metro Center Metro Station. Metro fare from Reagan National Airport (DCA) is $2.30 (one-way; Blue Line).

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 this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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