Webinars on demand

In questa sezione sono a disposizione tutti i webinar già organizzati da PDA Italy.
In fondo alla pagina seguendo le istruzioni di acquisto è possibile accedere alla registrazione video e alla relative presentazioni di interesse.


Depirogenazione: dal PDA tech report 7 alla serie USP 1228 - (1 ora)
Relatore: Alessandro Pauletto (Charles River Micorbial Solutions)


Annex1: come interpretare il draft per la seconda consultazione - (1 ora)
Relatori: Lucia Ceresa (Charles River Microbial Solutions), Gilberto Dalmaso (GDM Pharma Consulting)

  • La struttura del documento proposto per la seconda consultazione, a partire dalle fasi di commenti e l’iter di correzione da parte del Working Group (WG): PIC/s, EC, WHO.
  • I punti che sono ancora aperti ai commenti da parte delle associazioni
  • Quali le sessioni che non saranno più oggetto di revisione?

Panoramica e requisiti di qualifica nei diversi processi produttivi - (1 ora)
Relatori: Gilberto Dalmaso (GDM Pharma Consulting), Andrea Simonetti (Xepics SA, Switzerland)

  • descrizione e analisi degli aspetti critici dei diversi processi
  • le specifiche fasi di qualifica e i nuovi documenti richiesti
  • complementarietà delle utilities: acqua, vapore, gas e vuoto
  • APS - Aseptic Process Simulation
  • VI-Visual Inspection e CCI-Container Closure Integrity

Monitoraggio ambientale: un intero nuovo capitolo! - (1 ora)
Relatori: Gilberto Dalmaso (GDM Pharma Consulting), Lucia Ceresa (Charles River Microbial Solutions)

  • I nuovi livelli qualitativi stabiliti
  • L’approccio del controllo della contaminazione nelle aree classificate
  • Metodiche analitiche e criticità del monitoraggio incluso il personale
  • Requisiti per il monitoraggio delle cleanroom
  • Definizione dei limiti e importanza dell’analisi del trend

Come è cambiata la figura professionale nelle produzioni farmaceutiche - (1 ora)
Relatori: Gilberto Dalmaso (GDM Pharma Consulting), Lucia Ceresa (Charles River Microbial Solutions)

  • i criteri di assunzione, responsabilità e capacità
  • i criteri educazionali
  • razionale nella definizione dei training
  • criteri di qualifica e di controllo degli operatori

L'impatto della revisione dell'Annex 1 sul test di prodotti parenterali - (1 ora)
Relatore: Andrea Sardella (Stevanato Group)

  • Visual inspection: come il QRM influisce sulle strategie da implementare per la ispezione visiva. Criteri di qualità, validazione e trending.
  • Contamination Control Strategy and Quality Risk Management nell’ambito del CCI.
  • CCI and Annex 1: da sterility test a closure testing. Implicazioni sulle metodologie di test e sulle technologie a disposizione.

Annex 1: Il nuovo capitolo delle Utilities, in particolare WFI e Pure Steam - (1h:30)
Relatori: Paolo Curtò (DOC), Gilberto Dalmaso (GDM Pharma Consulting)

  • Water Systems: points to consider in the final draft?
  • Steam used as direct sterilizing agent: points to consider in the final draft?

PDA Technical Report 79-Particular Matter Control in Difficult to Inspect Parenterals - (1 ora)
Relatore: Andrea Simonetti (Xepics SA)

  • Regulatory requirements and applicable Standards
  • PDA Survey on DIP Products
  • Expectation for DIP inspection
  • Inspection approaches for DIP products/containers/devices

Process Validation: a regulatory requirement and key enabler for continual improvement - (1h:30)
Relatori: Mauro Giusti (Eli Lilly), Salvatore Di Nottia (Bracco)

  • Process Validation:
  1. provide High level Overview of Process Validation (PV) Concepts
  2. highlight some aspects of PDA TR 60
  • Process Validation as enabler of Continual Improvement (CI):
  1. focus on CPV/OPV and path forward to CI

Sterilizing Filtration: Current Practice to Implement and Execute PUPSIT - (1h:30)
Relatore: Renato Lorenzi (Merckgroup)

  • Quick refresh on Filter Integrity test theory
  • Current EMA and FDA regulations on filter integrity testing
  • Case studies on how to implement PUPSIT in different scenarios

Data Integrity Basics - (1 ora)
Relatore: Danilo Neri (PQE)

  • Regulatory expectations in a rapidly evolving business space
  • Current Enforcement on Integrity of Regulated Data
  • Data Integrity Principles
  • Data Governance System
  • Integrity requirements for Outsourced Services

PDA Technical Report 77 - The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology - (1 ora)
Relatore: Rajeev Kabbur (Brevetti Angela)

  • Blow Fill Seal Technology
  • Benefits and Special Considerations
  • Operational and Qualification Considerations
  • Quality Risk Assessment

Contact materials qualification - (1 ora)
Relatori: Antonio Legnani e Andrea Giuzzi (D.O.C. Validation)

  • Focus on E/L
  • Regulatory Overview
  • BPOG vs. Simulation Study
  • RA approach on overall process materials

The Medical Device Regulation – Guidance for Pre-filled Syringes and Combination Products - (1h:30)
Relatori: Michele Simone (Bracco) - Andrea Salmaso, Fabrizio Bacelle, Ankica Jakovljevic (Stevanato Group) - Simone Antonini (TÜV Rheinland)

  • PDA Webinar Series and Moderation of the day
  • Introduction of the topic
  • PFS and Combination Products Design and Development
  • Technical, Quality and Safety Information Requirements in Annex I Applicable for Prefilled Syringes and Major Implications
  • Notified Body Opinion
  • PDA Technical Report Proposal
  • Interactive Live Q&A and Discussion

Cybersecurity and the Life Sciences sector: how real is the threat? - (1h:30)
Relatore: Danilo Maruccia, PQE Group

Cybersecurity threats are constantly evolving and life science organizations are increasingly becoming a target. Cybercriminals worldwide, belonging to organized groups and quite often to state-sponsored organizations, continue to develop new techniques to gain access to sensitive data and assets. It’s not just the money what they are looking for, as in most cases they seek valuable intellectual property.

As a part of the workshop, a real example of modern offensive threats will be shown.


Sterilizing filtration: validation of specific products and processes, regulatory and technical aspects - (1h:30)
Relatore: Antonio Legnani, D.O.C.

  • Filtration Layout and VMP
  • Basic Qualification data vs Process
  • Regulatory overview
  • Validation Assessment
  • Bracketing & Grouping approach
  • Validation Maintenance

How to design, implement and maintain an effective Quality Risk Management: specific tools and case studies - (1h:30)
Relatore: Michele Simone, Bracco Imaging

Since January 2006 when ICH Q9 came into effect, QRM principles and framework were helpful in introducing QRM approaches to pharma industry. However, as experienced at many companies, the benefits of QRM have not yet been fully realized. This webinar designed to provide you with the tools and techniques to improve your decision-making skills and better protect your company and the patient. We will show you how to take a structured, risk-based approach to problem solving and decision making, using techniques such as failure mode effect analysis (FMEA), hazard analysis critical control point (HACCP), 5 whys and fishbone diagrams. We will provide you with the skills and tools to take better decisions at work!

We will provide you the framework and the roadmap designed at ICH to plan the revision of ICH Q9:

  • Chapters 1 and 4.1: Increase objectivity to risk through well-recognized strategies
  • Chapters 1 and 5: Define the required formalities in QRM
  • Chapters 1 and 6: Clarify how to achieve a better risk-based decision making
  • Chapters 6 and 7: Allow better supply chain predictability through a risk based approach.

A specific session will be designed to present the most appropriate risk culture to ensure that staff accept the importance of effective operational risk management and behave in a manner consistent with the organisation’s operational risk policies, procedures, and appetite.

Bullet points of the webinar:

  • Introduction to Risk-based decision-making – The theory
  • Practical implementation and use of ICH Q9
  • The future of ICH Q9
  • QRM Tools: FMEA, Fishbone diagrams and many more techniques
  • The Risk Culture

Selection criteria for most suitable Container Closure Integrity method: matching the method to User Requirements Specifications and regulatory expectations - (1h:30)
Relatore: Andrea Simonetti, Xepics

  • Why Container Closure Integrity is Needed?
  • Regulatory requirements and Standards on CCI
  • Container Closure Integrity Methods
  • Advantages and Drawbacks of CCI Methods
  • Choose the Most Appropriate Method

Integrity Test Troubleshooting Management - Beyond Rewet and Retest - (1h:30)
Relatore: Renato Lorenzi, Merck Life Science

  • Integrity testing fundamentals
  • Understanding the possible causes of IT failures
  • How to apply a logical step-by-step re-test procedure to distinguish between a false failure and a real failure
  • Developing internal trouble shooting SOP to establish the root cause of IT failures

MODALITA' DI ACQUISTO

Quota di iscrizione per ciascun webinar: €200,00 (iva inclusa)

Contattare la segreteria (pda@pda-it.org) indicando il/i webinar/s di proprio interesse. Successivamente alla ricezione del saldo della quota di iscrizione, verrà inviato via e-mail il link univoco alla registrazione del corso e la presentazione dello stesso, per la fruizione asincrona della formazione.
Verrà emessa regolare fattura dalla Segreteria Organizzativa CCI srl.

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