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Validation of Biotechnology-Related Cleaning Processes - Option 1

Jun 26 - Jun 28, 2019
Bethesda, MD

  • Education
  • The Americas

Overview

Based on PDA Technical Report #49, Points to Consider for Biotechnology Cleaning Validation, this complete, hands-on training course covers both automated clean-in-place (CIP) and manual cleaning for biotechnology manufacture.

During this training course, you will have the opportunity to work with a functional CIP skid to help you understand everything from the impact of system design on cleanability to how to take swab samples and set acceptance criteria. You'll gain direct experience setting up an effective cleaning program by going through a systematic approach to cleaning validation. Areas of focus include initial evaluation of the equipment to be cleaned, analytical techniques, worst-case conditions, multi-product cleaning, cleaning cycle development and validation of the cleaning process.

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

Rebecca Brewer
Rebecca Brewer
Quality Executive Partners

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the principles of cleaning and cleaning validation
    2. Describe CIP system design and operation
    3. Analyze cleaning engineering, physics and mechanics
    4. Develop cleaning validation protocols for CIP systems and cleaning processes
    5. Discuss numerous cleaning validation tips, techniques and pitfalls
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved with equipment cleaning processes that support sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering

    Roles
    Technician, Analyst, Specialist, Supervisor, Manager, Engineer

  • 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: 575 / 0116-0000-17-030-L04-P / 1.8
    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 18 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 18 PDH credits.

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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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

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

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By May 10, 2019
Member $3,419
Non-member $4,103
Gov't/Health Auth./Academic* $2,279



Regular Registration
Registration Type Price After May 10, 2019
Member $3,799
Non-member $4,559
Gov't/Health Auth./Academic* $2,279



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

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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]

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