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2019 BioManu

Best Practices and Points to Consider in Aseptic Processing

Sep 05 - Sep 06, 2019
Munich, Germany

Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject.

  • Education
  • Europe
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Program Highlights

Overview

Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all.

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Agenda

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  • Day 1
  • Day 2

  • Thursday, 05 September 2019

    9:00
    Welcome and Collection of Participant Expectations

    9:30
    Introductional Test about Selected Hot Topics in Aseptic Processing

    • Discussion of answers
    10:30
    Coffee Break

    11:00
    Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

    • Steam & Dry Heat Sterilization
      • Moist Heat sterilization (Fo- Concept)
      • Dry Heat Depyrogenation
      • What can go wrong and common Audit findings
      • Following PDA TRs are briefly addressed:
        • Technical Report 1 (TR 1) / TR 3 / TR 48 / TR 61
    • Key elements for Cleaning & Disinfection in cleanrooms
      • Procedures and Best Practices
      • Common mistakes and audit finding
        • TR 70 Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing
    • Gowning steps for entering grade A/B area
      • Teamwork
      • Important points to consider
    12:30
    Lunch Break

    13:30
    Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures (cont.)

    14:30
    Team Excercise 1: How to Build Up a New Aseptic Filling Line

    15:30
    Coffee Break

    16:00
    Aspects of Clean Room Concepts and Good Aseptic Working Practices

    • Conventional filling lines
    • RABS and isolators
    • Understanding First Air and barrier concepts
      • TR 62 Recommended Practices for Manual Aseptic Processes
    • Points to Consider for Aseptic Processing: Part 1 & Part 2
    • Update on new PDA TR Points to Consider for Isolators
    17:30
    End of Day 1

  • Friday, 06 September 2019

    9:00
    Best Practices in Aseptic Processing Simulation

    • Basic Concepts and Regulatory Framework about Process Simulations
    • Best Practices in Media Fills for Finished Dosage Form and API
      • TR 22 Process Simulation for Aseptically Filled Products
    • (Re)Qualification of Operators
    • Categorization of Interventions

    10:00
    Effective Oversight at the Shop Floor, Good Training Methods

    • Regulatory requirements and framework
    • Sharing my best practices and effectiveness
    • Examples from the shop floor worldwide
    10:30
    Coffee Break

    11:00
    Important Aspects in Environmental Monitoring

    • TR 13 Fundamentals of an Environmental Monitoring Program
    • Regulatory requirements and expectations
    • Rationale for sample locations and frequency

    11:30
    Team Exercise 2: Set-up a EM Program for Cleanrooms/Isolators

    12:30
    Lunch Break

    13:30
    Team Exercise 3: Share your own case studies and problems, and find resolutions as a team

    15:00
    Coffee Break

    15:30
    Team Exercise 4: Benchmarking between team members

    16:30
    End of Course

Trainers

Guenther Gapp
Guenther Gapp
Gapp Quality GmbH
Bio
Guenther Gapp
Gapp Quality GmbH

Since 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe and has been engaged in approximately 50 projects e.g. in assignments for remediation of companies cited with a Warning letter. In the previous steps of his career, he served in the pharmaceutical industry during 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert and Troubleshooter in global projects and supplier audits. During this period, he gained in-depth experience in Aseptic processing key elements and Risk Assessments, Training and motivation of operators, media fill practices of finished dosage forms and bulk products, environ- mental monitoring, rapid testing methods and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA audits.

He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years. Since 2017 he has been member of PDA´s EU Annex 1 Revision Commenting Task Force, Science Advisory Board and Co-Chair in the Isolator Taskforce.

Additional Information

  • Learning Objectives

    Learning Objectives

    • Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
    • Understand key requirements and challenges in parenteral production
    • Understand the importance of a good quality culture within a company
    • Apply the executed and presented case studies and team exercises in her/his daily job
    • Get answers and interpretations about - potentially - unresolved questions and problems
    • Gain confidence for audits
  • Who Should Attend

    Who Should Attend

    Personnel involved in Aseptic Processing from sterile production departments such as:

    • Production Management and Shop Floor Supervisors
    • QA and QC Microbiologists
    • Qualified Persons
    • Personnel from technical department

    A basic understanding of Aseptic Processing is a prerequisite.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Sheraton Munich Arabellapark Hotel

Arabellastraße 5
Munich, Germany
Phone: +49 (0)89 9232

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 7th July 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 169 per night* 
    Double Room € 194 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 will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone: +49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* 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.

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