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Parenteral Drug Association Connecting People, Science and Regulation ®

Environmental Monitoring and Contamination Control

Oct 17 - Oct 18, 2018 |
Oct 18, 2018 |
Berlin Marriott Hotel | Berlin, Germany
  • Education
  • Europe
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Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies. This fact is highlighted in the revised version of Annex 1. Contamination control for sterile, non-sterile, low-bioburden and cell and gene therapy manufactured products will all be included in this course with discussions around the differences in each area.

This two-day training course will be a complete review of all aspects of a contamination control program. A review of the regulation and requirements will be performed along with discussions around practical deployment of the requirements as well as challenges and solutions.

This interactive course will provide a detailed review on how to establish and maintain an effective risk based EM Program. Cleanroom classification, HVAC Qualification (EMPQ) and routine environmental monitoring requirements and best practices will be discussed along with establishment of cleaning/disinfection programs and disinfectant efficacy testing. EM alert/action level setting, EM excursion investigations and microbial identifications will be discussed.

Who Should Attend

  • Manufacturing - Supervisors/Managers/Specialists
  • Quality Control - Managers/Specialists/Technicians/Microbiologists
  • Quality Assurance - Managers/Specialists/Technicians/Microbiologists
  • Validation - Supervisors/Managers/Specialists/Technicians
  • Engineering - Supervisors/Managers/Specialists/Technicians

Learning Objectives

  • Apply current regulatory guidance to your environmental monitoring program and contamination control strategies
  • Review and discuss the NEW contamination control requirements in the revised Annex 1
  • Understand the requirements of cleanroom classification and ongoing monitoring according to ISO 14644-1,2
  • Describe and discuss industry best practice and requirements for establishing cleaning and disinfection programs
  • Discuss disinfectant efficacy studies
  • Describe how to implement environmental monitoring risk assessments
  • Understand differences in EM requirements for non-sterile, low-bioburden, cell and gene therapy and sterile product manufacturing
  • Discuss how to create and perform EM performance qualifications (EMPQ)
  • Compare and contrast new and existing environmental monitoring equipment
  • Explain how to conduct EM investigations
  • Describe how to establish EM alert and action levels and how to prepare meaningful trend reports
  • Describe and review microbial identification instruments and methods
  • Understand how to establish the best microbial control strategy for your company

Faculty

Marsha Steed , Senior Consultant, ValSource
Marsha Steed has over 25 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. She is a Senior Consultant for ValSource and in this role, helps companies implement quality risk management into their quality management systems and validation programs. Marsha specializes in helping companies develop risk based environmental monitoring programs and perform microbial risk assessments. She also provides many training courses and webinars for aseptic processing, cleanroom classification and facility startup. Marsha is an expert in Cell and Gene Therapy. She is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB). She is member of the PDA Task Force on Microbial Investigations, the PDA Microbiology Program Planning Committee and she has been the past chair of the PDA Annual Meeting. Marsha is a former notified body ISO auditor.

Wednesday, 17 October 2018

9:00
Welcome & Introduction


9:15
Guidance and Regulations

  • FDA Sterile Guidance
  • Annex 1 2008 and revised version
  • ISO 14644
  • USP/EP
  • PDA TR13 ‘Fundamentals of an Environmental Monitoring Program’

10:30
Coffee Break

11:00
Classification of Cleanrooms and EMPQ

  • ISO 14644-1 & 2
  • Selection of representative sample locations
  • Use of risk
  • Periodic classification
  • Baseline studies
  • Environmental Monitoring risk assessments
  • Static and Dynamic EMPQ

12:30
Lunch Break

13:30
Establishing Cleaning and Disinfection Programs

  • Selecting agents
  • Mopping
  • Rotations
  • Disinfectant Efficacy Studies

15:30
Coffee Break

16:00
EM Risk Assessment Methods

  • EM-REM
  • FMEA
  • HACCP

18:00
End of Day 1

Thursday, 18 October 2018

9:00
Environmental Monitoring Equipment

  • Sampler types for viable and nonviable
  • Microbial ID EQ

9:30
Environmental Monitoring (EM)

  • Non-viable particulates
  • Viable air and surface
  • Surface particulates
  • Personnel EM
  • Frequency of monitoring
  • Number of samples
  • Growth promotion of media
  • Establishing EM SOPs
  • In-house vs. CTO options
  • EMPQ

10:30
Coffee Break

11:00
EM for Different Manufacturing Processes

  • Sterile Products
  • Low Bioburden
  • Non-sterile
  • Cell and Gene Therapy

12:30
Lunch Break

13:30
EM Trending

  • Establishing alert and action levels
  • Meaningful trending and reporting
  • Use of EM Software

14:30
EM Investigations

  • Conducting EM Investigations

15:00
Coffee Break

15:30
Microbial Identifications


16:00
Summary, Q&A

16:30
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

1495 Euro

Contact

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

Exterior

Berlin Marriott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 14th August 2018.
Book your room for the PDA Group Rate.

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4501

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