PDA Italy Chapter: Inspection of Parenteral Products: State of the Art, Annex 1 Compliance and New Trends

Travagliato BS, Italy
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Program Highlights

GENERAL INFORMATION:

LANGUAGE

The official language is English. No simultaneous translation is provided. The presentations (ppt slides) will be in English.

ORGANIZING COMMITTEE

  • Filippo Trionfera (BSP Pharmaceutical), Chairman
  • Mirko Gabriele (PDA Italy Chapter President Elect, Consultant)
  • Gabriele Peron (Stevanato Group)
  • Andrea Simonetti (Consultant)
  • Claudio Puglisi (Entourage)
  • Giuseppe Petrosino (Antares Vision Group)
  • Afaf Lahjel (Antares Vision Group)
  • Carlo Marconi (Antares Vision Group)

PDA Italy Chapter is pleased to announce “Inspection of Parenteral Products: State of the Art, Annex 1 Compliance and New Trends” in association with Antares Vision on 28-29 September 2023. Two days fully dedicated to the latest developments in relation to visual inspection with a deep focus on the impact of new regulations, automated systems and best practices learnt by real cases.

At this event, we will present and discuss new developments and expectations in the field of Visual Inspection, which continues to be critical to manufacturing and delivering high-quality injectable medicines.

Starting from the regulatory scenario, which continues to evolve rapidly with new or revised guidance, we will investigate VI's new requirements and implementation within pharmaceutical manufacturing.

Special attention will be given to difficult-to-inspect parenteral (DIP) products, such as lyophilized products, and to the role of Container Closure Integrity Testing. Technological advancements, like the use of AI in image analysis and predictive maintenance, will also be discussed.

The agenda will include a guided tour at the Antares Vision Group plant dedicated to inspection machines with the opportunity to visit the test laboratory and the production area.

Event Location
Novotel Brescia 2 and AC Hotel Brescia
Via del Ferro, 16, 25039 , Travagliato BS, Italy Get Directions

Contact

Chapter Inquiries
Tel: +1 (301) 656-5900
Membership Services

Standard Registration

Member Price

€ 366,00

Day 1

  • 12:30 - 14:00 | Arrival, registration & welcome buffet
    • REGISTRATION & WELCOME
  • 14:00 - 14:15 | Opening Remarks and Proposed Discussion Topic Mirko Gabriele, PDA Italy Chapter President Elect
  • 14:15 - 14:30 | Welcome and Introduction Giuseppe Petrosino, Business Owner, Inspection Machines Antares Vision Group
  • 14:30 - 15:00 | Regulatory scenario & Highlights on New Annex1 Andrea Simonetti, Consultant
    • VISUAL INSPECTION
  • 15:00 - 15:30 | What to Inspect? Cosmetics, Fill Level & Particle Detection Highlights. Carlo Marconi, Inspection Machines SME Andrea Simonetti, Consultant
  • 15:00 - 15:40 | Learnings & Experience Implementing an AIM for Sterile Powder Vials – F. Hoffmann La Roche Case Study Thea Schweigler,Technical Unit Lead Antibiotic Production Michael Rüttnauer, Process Manager Optical Inspection Philipp Gleichert, Process Manager Antibiotic Production
  • 15:40 - 16:00 | Sponsor Highlights
  • 16:00 - 16:15 | Coffee Break
    • DIFFICULT TO INSPECT PRODUCTS:
  • 16:15 - 16:45 | How to Handle the Visual Inspection of Non-Transparent Products and Suspensions - Fisiopharma Case Study Vincenzo Abbatemarco – Production Manager Edoardo Schettino – Manufacturing Quality Assurance
  • 16:45 - 17:15 | Reference Standard Test Sets for the Visual Inspection of Parenterals. Highlights on LYO Products and BFS Cards Test Kit Preparation Swen Maas, Managing Director, Material Analytic Service Laboratory
  • 17:15 - 17:45 | LYO Products & BFS Cards Inspection Techniques Alberto Reghenzi,AV Group Inspection Machines R&D SW Manager Simone Mainardi,AV Group Inspection Machines Test Lab Manager
  • 17:45 - 18:15 | Panel Discussion with all Speakers, Chair Marisa Delbò, former Senior GMP Inspector & Closing

    • Pickup and Transfer to Partner Hotel Provided by Antares Vision Group Networking Dinner Experience at the Heart of “Brescia Capitale della cultura 2023” (BS)

    Italy Chapter dinner venue

Day 2

  • 8:30 | Meeting point at hotel and transfer to Antares Vision Parma facility
  • 10:15 - 10:45 | Inspection of Parenteral Products – GMP Inspection prospective Lorella Chiappinelli, AIFA Senior GMP Inspector - invited
  • 10:45 - 11:15 | Integrity testing methods & High Voltage Implementation - Riccardo Giannone, CCIT R&D Specialist, AV Group
  • 11:15 - 11:30 | Coffee Break
  • 11:30 - 13:00 | Laboratory & production tour and live demos
  • 13:00 - 14:00 | Lunch
  • 14:00 - 14:30 | Validation approaches & strategies
  • 14:30 - 15:00 | Visual Inspection with AI & Predictive Maintenance - Orobix
  • 15:00 - 15:30 | Panel Discussion with all speakers, Chair Marisa Delbò, former Senior GMP Inspector & Closing
Agenda is subject to change.

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.

Novotel Brescia 2 and AC Hotel Brescia

Via del Ferro, 16, 25039
Travagliato BS, Italy , Italy

Venues

Congress Venue
Antares Vision Group Via del Ferro, 16, 25039 Travagliato BS info@antaresvision.com.

Manufacturing Plant Tour at Parma Facility
29 September, 2023 Via Caduti del Lavoro, 13, 43058 Sorbolo Mezzani PR


Novotel Brescia 2 – Via Pietro Nenni, 22, 25124 Brescia booking email: ha0z4-sl@accor.com.

AC Hotel Brescia – Via Giulio Quinto Stefana, 3. 25126 Brescia booking email: reception.brescia@acmarriott.com.

While booking, refer to "PDA MEETING ANTARES VISION".