Quality Risk Management (ICH Q9) & Pharmaceutical Quality System (ICH Q10): Applications in the Pharmaceutical Sector

Quality Risk Management (ICH Q9) & Pharmaceutical Quality System (ICH Q10): Applications in the Pharmaceutical Sector

Topics
  • Quality Risk Management & Applications in the Pharmaceutical Field
  • Change Management, Deviations, Investigations & CAPAs
  • Suppliers Management: Technical Agreements & Audits

Who should attend

Quality Assurance, Quality Control, Plant Managers, Regulatory Affairs, Business Development, Procurement

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Day 1 - Thursday 23 April 2015
  • 09:00 – 09:30 REGISTRATION – ATTENDANCE
  • 09:30 – 09:45 WELCOME – OPENING REMARKS
  • 09:45 – 10:15 GMP Update: Quality Risk Management (ICH Q9) and Pharmaceutical Quality System (ICH Q10)
  • 10:15 – 11:00 Quality Risk Management: Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S
  • 11:00 – 11:30 COFFEE BREAK
  • 11:30 – 12:30 Overview and practical application of the main Risk Assessment tools: FTA, FMEA and FishBone Analysis
  • 12:30 – 13:15 Application of Quality Risk Management to aseptic process
  • 13:15 – 14:30 LUNCH BREAK
  • 14:30 – 15:15 Application of Quality Risk Management to set Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas
  • 15:15 – 16:00 Risk-based Methodology for Process Validation: practical application of the new FDA lifecycle approach
  • 16:00 – 16:45 DISCUSSION QUESTIONS AND DEBATE
Day 2 - Friday 24 April 2015
  • 09:00 – 09:15 ATTENDANCE
  • 09:30 – 10:15 Change management: regulatory references and risk assessment tools
  • 10:15 – 11:45 Change management: risk based approach to Quality and Compliance – Case studies presentation
  • 11:45 – 12:15 COFFEE BREAK
  • 12:15 – 13:15 Deviation and CAPA management: regulatory references and root cause analysis application
  • 13:15 – 14:30 LUNCH BREAK
  • 14:30 – 15:15 Audit Lifecycle and efficient auditing tools
  • 15:15 – 16:00 Suppliers qualification and Risk-based approach to set auditing schedule
  • 16:00 – 16:45 DISCUSSION QUESTIONS AND DEBATE
EARLY REGISTRATION FEES (for registrations received before February 28th, 2015)
Industry Early Registration Fee € 600.00
Reduced Early Registration Fee
(for Academia, Full Government, Students & Unemployed)
€ 300.00
STANDARD REGISTRATION FEES (for late or on-site registrations)
Industry Standard Registration Fee € 800.00
Reduced Standard Registration Fee
(for Academia, Full Government, Students & Unemployed)
€ 400.00

Event Speakers


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Bank Transfers: Payments should be addressed to:
PHARMASSIST Ltd
BANK: ALPHA BANK
ACCOUNT: 153 00 2320 002897
IBAN: GR14 0140 1530 1530 0232 0002 897
including your name, company and Meeting ID: 04/03.

Cheques should be made payable to: PHARMASSIST Ltd (ΦΑΡΜΑΣΙΣΤ ΜΕΠΕ) and mailed together with a copy of the registration form to facilitate identification to:
PHARMASSIST Ltd, 262 Messogion Av. 155 62 Holargos, Athens, Greece

Payments must be net of all charges and bank charges must be borne by the payer.

CANCELLATION POLICY

Registrants who do not cancel five working days prior to the seminar start date and do not attend, will be responsible for the full registration fee.
PHARMASSIST reserves the right to alter the dates, if necessary.