Skip To The Main Content

Establishment of a Risk-Based Environmental Monitoring Program

Oct 25, 2019
Rockville, MD

  • Education
  • The Americas

left to save

Overview

This training course will review routine environmental monitoring (EM) program requirements, EM program qualification requirements, use of risk tools for determination of microbial contamination sources in production environments and processes, and EM risk assessment tools and instruction on how to perform them.

Limited information and guidance currently exist on how to conduct EM risk assessments. Current regulatory requirements prescribe that sample site locations and sampling frequencies must be risk-based with documented rationales, but there is little to no guidance on how to perform these types of risk assessments. There is currently large interest in the industry for guidance on this topic.

This training course will present information on the establishment of a risk-based EM program. It will cover both the establishment of new as well as reassessment of current EM programs to bring them into compliance with industry standards. Routine EM program requirements and EM program qualification requirements will also be reviewed. Instruction will be given on the use of risk tools for determination of microbial contamination sources in production environments and processes, and on the use of EM risk assessment tools.

There will be small group breakouts for completion of EM risk assessments: Fishbone Diagrams, FMEAs and HACCPs. The goal of this training course is to understand the tools available for conducting EM risk assessments and how to properly utilize them to create risk-based EM programs.

Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

Marsha  Steed
Marsha Steed
Valsource, LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss global requirements for the establishment risk-based EM programs
    2. Utilize assessment tools are available for EM risk analysis
    3. Perform EM risk assessments utilizing risk tools (Fishbone, FMEA, HACCP)
    4. Establish risk-based EM programs at your company
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved assessing risk associated with their company’s environmental monitoring program.

    Departments
    Quality Control, Quality Assurance, Validation

    Roles
    Specialist, Analyst, Supervisor, Manager, Microbiologist

  • 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:

    PDA # / ACPE # / CEUs: 347 / 0116-0000-18-005-L04-P / 0.6
    Type of Activity: Application

    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.
    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 (PDH) 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 PDH credits.

Got a Question? We have answers

Contact Us

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

Make a Reservation
  • 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 Bethesda North Marriott Hotel & Conference Center. The rate is $249 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Bethesda North Marriott Hotel & Conference Center at +1 (301) 822-9200. Please make 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 6:00 p.m. (EDT) on the date of arrival 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

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 September 10, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839

Regular Registration
Registration Type Price After September 10, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839

* 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 25, 2019, no fee will be charged. After Sep 25, 2019, 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 25, 2019, a full refund will be given minus a $200 fee. After Sep 25, 2019, 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.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially