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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

  • 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 systems 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

  • 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

For the past five years, the microbiologist Guenther Gapp has been working as an independent consultant with different clients and contractors worldwide  (> 35 projects in USA, India, Brazil and Europe). In many projects he has been engaged as “Aseptic Processing Expert” for projects worldwide in remediation of companies cited with Warning Letters, and in Audits, Man in Plant and Remediation assignments. In his previous career, Guenther spent 20 years in the pharmaceutical industry as Head of QA/QC Microbiology and as Sterility Assurance Expert and Troubleshooter. During this period, he gained in-depth experience in aseptic processing key elements, and has been a subject matter expert in 20 FDA audits. Guenther also created a new sterile risk assessment tool (SPCRA) to identify and reduce the microbial contamination and compliance risk of sterile products, and this method is now in use worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award.

Since 2017 Guenther is member of the PDA Task Force group dealing with the EU Annex 1 revision, and in the recognized PDA Science Advisory Board. Since 2018 he is Co-Chair of the new PDA Task Force “Isolator Technology in the Pharmaceutical Industry”. 

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

    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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Sheraton Munich Arabellapark Hotel

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

Make a Reservation
Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website
    Tel.: +49 (0)89 92320

    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 15th June 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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