Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Mastering Environmental Monitoring

Sep 04 - Sep 05, 2018 |
Sep 05, 2018 |
TBD | Wattwil, Switzerland
  • Education
  • Europe
Add event to: ICal Outlook Google Calendar

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.

Who Should Attend

This course is designed for

  • Lab Supervisors
  • Manufacturing Supervisors
  • QC Managers
  • QA Managers
  • Manufacturing Managers
  • Lab Staff
  • Auditors and Regulators

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)

Instructors

Frank Panofen, PhD, Senior Consultant, Particle Measuring Systems
Over the last 15 years with Merck, Frank Panofen gained proven expertise in traditional microbiological topics like sterility testing and bioburden analytics and a long experience on the implementation and development of new rapid technologies for the pharmaceutical industry. Today, Frank is the Product Line Manager for Sterility Assurance/Microbiology products at Particle Measuring Systems, globally responsible for all products related to industrial microbiological testing, with a strong focus on environmental monitoring. He is certified Microbiological Laboratory Manager from ECA. Frank gained a Diploma in Chemistry from the University of Bielefeld and a PhD in molecular and cell biology from the University of Osnabrück.


Gilberto Dalmaso, PhD, Global Product Line Manager Microbiology & Sterility Assurance, Particle Measuring Systems
Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK) where he started in 1984. Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM). Today Gilberto is the Senior Advisor and Global Pharma Customer Advisory Team Manager for Particle Measuring Systems. In this role and with his team of subject matters experts, he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.


Marcel Goverde, PhD, Managing Director, MGP Consulting
Marcel Goverde gathered first work experience as scientific collaborator in the agro biological section of Novartis. From 2002-2010 he led several QC labs for microbiology at F. Hoffmann-La Roche Ltd. From 2010-2011 Marcel worked as a QC expert for microbiology at Novartis Pharma Ltd. Since 2011 he leads his own business for consulting, training, project and deviation management named MGP Consulting GmbH. Marcel is a regular speaker at different institutions and has written several scientific papers. He is the Swiss expert in the EDQM group for modern microbiological methods since 2003. Marcel studied biology at the University of Basel, where he gained his PhD in 2001.

Tuesday, 4 September 2018

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, 5 September 2018

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

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1595 Euro

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

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

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

Sponsorship and Exhibit Opportunities are not Available for this Course!

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4150

Directions