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2019 Environmental Monitoring

Mastering Environmental Monitoring

Oct 15 - Oct 16, 2019
Wattwil, Switzerland

This two-day course is set up as a highly interactive event with hands-on lab training sessions and workshop sessions on risk analysis and design of Environmental Monitoring. The lecture part will cover current regulations, methods and devices.

  • Education
  • Europe

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Program Highlights

This Course will be held at the CAS Clean-Air-Service AG Facility in Wattwil.

Overview

Environmental Monitoring (EM) is one of the key pillars to ensure aseptic manufacturing. It covers particle measurement and hygiene monitoring (air and surface sampling). This two-day course is set up as a highly interactive event with hands-on lab training sessions and workshop sessions on risk analysis and design of Environmental Monitoring. The lecture part will cover current regulations, methods and devices. All participants are invited to bring their own case studies or audit findings and questions to be discussed in the group. The group has the unique opportunity to visit the calibration lab of CAS to see calibration of devices in action.

Agenda

  • Day 1
  • Day 2
  • Tuesday, 15 October 2019

    9:00
    Welcome and Theory 1

    • Monitoring particles in air
    • Cleanroom classes and classification
    • Principles of ISO 14644 1 and 2

    10:30
    Coffee Break

    11:00
    Theory 2

    • Microbiological classification & monitoring of air, surfaces & personnel
      • Theory
      • Methods
    • Examples of devices

    12:15
    Lunch Break

    13:15
    Theory 3

    • Regulations and guidelines
      • GMP & EP/USP

    14:00
    Theory 4

    • Brief inside on EU GMP New Annex 1 with focus on EM

    14:30
    Coffee Break

    15:00
    Hands-on 1

    • Cleanroom 1: Realtime EM, Gowning exercise, contact plates surfaces / personnel
    • Cleanroom 2: Devices, software demonstration
    • Calibration lab: Calibration of devices, wind tunnel

    15:45
    Workshop 1

    • Risk analysis
    • Design of EM
    • Discussion of workshop results

    18:00
    End of Day 1

    18:30
    Networking Dinner
  • Wednesday, 16 October 2019

    8:30
    Hands-on 2

    • Clean room 1: Realtime EM, Gowning exercise, contact plates surfaces/personnel
    • Cleanroom 2: Devices, software demonstration
    • Calibration lab: Calibration of devices, wind tunnel

    10:00
    Coffee Break

    10:30
    Theory 5

    • Deviations/Investigations
    • Data trending
    • Data integrity

    12:30
    Lunch Break

    13:30
    Theory 5

    • Case studies (Discussion of findings on aseptic handling, data integrity, data trending for EM)

    15:00
    Wrap-up, Q&A


    15:30
    End of Course

Trainers

Gilberto Dalmaso
Gilberto Dalmaso
Particle Measuring Systems
Marcel Goverde
Marcel Goverde
MGP Consulting
Frank Panofen
Frank Panofen
Particle Measuring Systems

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this course the participants

    • have understood the principles of EM
    • can explain different methods of EM (microbial, particles), standard and advanced methods
    • have understood basic designs of EM program in facility or clean room
    • are able to give input to / perform a risk analysis
    • have understood impact of operator behaviour in cleanroom on EM
    • can operate EM devices
    • have understood principles of data trending and integrity
    • have understood current guidelines and regulations (including Annex 1 revision)
  • Who Should Attend

    Who Should Attend

    This course is designed for

    • Lab Supervisors
    • Manufacturing Supervisors
    • QC Managers
    • QA Managers
    • Manufacturing Managers
    • Lab Staff
    • Auditors and Regulators
  • 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:
    Type of Activity: Not Applicable

    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 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 PDH credits.

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Travel

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CAS Clean-Air-Service AG

Reinluftweg 1
Wattwil, Switzerland

CAS Clean-Air-Service AG
  • Accommodations

    CAS Clean-Air-Service AG
    Reinluftweg 1
    9630 Wattwill
    Switzerland


    Hotel Nearby

    PDA Europe recommends the reservation at the following hotel.

    The general terms of business are valid at the event hotel.

    Hotel-Restaurant Sternen
    Hauptstrasse 28
    9650 Nesslau
    Switzerland
    Tel: +41 71 994 19 13
    Hotel Website

    Located in the village of Nesslau, Hotel-Restaurant Sternen serves traditional Swiss cuisine and features a modern bowling alley and private fishing waters on the nearby Thur River.

    All rooms have a balcony with mountain and river views, a seating area with a flat-screen satellite TV, and a bathroom.

    Parking

    • Free parking available on site.
  • Amenities

How to Get Here

By Air

Nearest Airport: Zurich Airport – ZRH
Airport Phone:
+41 43 816 22 11

By Car

76.1 km, 57 min by car. CAS Clean-Air-Service AG is located at Reinluftweg 1, 9630 Wattwill, Switzerland.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (7,7%)

* 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 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 [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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