Essential Knowledge for the Pharmaceutical Industry: The Production of Tablets and Capsules

- Πρώτες Βοήθειες/ Υπηρεσίες Υγείας

28 Ιουν 2024 09:00 01 Ιουλ 2024 11:45
Αγγλικά
8 ώρες ( 2 μέρες )
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Essential Knowledge for the Pharmaceutical Industry: The Production of Tablets and Capsules

ΠΕΡΙΓΡΑΦΗ

The pharmaceutical industry is legally and strictly bound to fulfil the requirements of the European Union – currently Good Manufacturing Practices (EU-cGMP) as laid down in the corresponding European Directives and implemented into the National Laws of the Republic of Cyprus. These requirements must be embedded in the quality system of any production site, as a condition to obtain the legal authorisation to manufacture medicinal products. Continuous and appropriate training of personnel is a fundamental pillar on which this quality system must rest. 

This training programme will provide the essential knowledge which is required for personnel employed at the production site of the finished product dosage forms such as capsules and tablets. It will explain the technology and quality concepts in a manner intelligible to all participants, whether they join with or without prior educational background. Finally, this course contributes to develop a motivated and competent workforce who will be ready to engage in their daily task in a compliant manner.

ΣΚΟΠΟΣ ΣΕΜΙΝΑΡΙΟΥ

By the end of the programme, participants will be able to:

  • Describe the operations relevant to the production of tablets and capsules
  • List the type of packing materials and the ingredients of the formulation
  • Identify the pieces of equipment and utilities which support the production activities
  • Express the basic quality concepts
  • Order the production stages into the correct sequence of events and understand the link between each one of them
  • Develop knowledge common to all personnel at the production site
  • Perform their activities in a compliant manner
  • Explain the manufacturing operations they are involved with
  • Show a good understanding of the basic quality concepts
  • Challenge any non-compliant behaviour or activity which may jeopardise product quality
  • Justify their actions taken within the context of their daily task in a logical and competent manner
  • Participate in technical discussion at company level
  • Evaluate the need for improvement at their production site

ΣΕ ΠΟΙΟΥΣ ΑΠΕΥΘΥΝΕΤΑΙ

The programme is ideal for personnel at the production site of finished product dosage forms (capsules and tablets), such as:

  • Production operators
  • Production supervisors and managers at the early stage of their career
  • New personnel at the production site, such as:
    • Quality Control and Quality Assurance staff
    • Support Engineers
    • Prospective Qualified Person
    • Regulatory Affairs Personnel

ΠΕΡΙΣΣΟΤΕΡΕΣ ΠΛΗΡΟΦΟΡΙΕΣ

Training Outline 

Overall Presentation of the Production Site

  • A Highly Regulated Environment (the EU-cGMPs)
  • The Different Areas and Units
  • Key Personnel
  • The Medicinal Product: Tablets and Capsules 

Manufacturing Technology for Tablets and Capsules

  • Formulation and Packing Materials
  • The Production Process
  • Supporting Utilities
  • Calibration, Qualification and Validation 

Case Study – A Case Study of the Drugs and Pharmaceutical Industry 

Fundamental Quality Concepts

  • Quality Assurance and Quality Control
  • Documentation
  • Hygiene and Environment Control
  • Cross-Contamination and Mismatch Prevention
  • Non conformances 

Case Studies –  Pharmaceutical Quality Control Case Studies


Training Style

The programme has a practical delivery style with presentations, case studies, practical exercises, and direct-action points that will help participants apply the knowledge learned to keep their organisation compliant and the employees motivated and competent. 

CPD Recognition 

This programme may count towards a person’s Continual Professional Development (CPD) requirements (up to 7.5 CPD Units). Eligibility criteria and CPD Units are verified directly by your association, regulator or other bodies which you hold membership.


Trainer: Dr Jean-Philippe Cros

With 20 years of experience in the Pharmaceutical Industry in the E.U., Dr Jean-Philippe Cros brings a wealth of expertise as a service provider and consultant. A registered Qualified Person since 2010, Jean-Philippe specializes in Quality Assurance, Batch Certification and Technical Operations (including Validation, Manufacturing, Warehousing, Distribution, and Project Management). He currently manages his own company, providing comprehensive services for the Pharmaceutical Industry. In the past, Jean-Philippe led the Quality Unit of an Oral Solid Forms production site (200 employees), taken part in over 40 quality audits and inspections, coordinated major construction projects, and managed routine batch release activities for several years. He also led the validation and qualification activities of a medium size (600 employees) manufacturing site and he later took the responsibilities of Production Management, overseeing production programming, operational troubleshooting, staff training, performance indicators implementation, and engineering activities. Jean-Philippe Cros is also the holder of a Ph.D. in Organic Chemistry from the University of Bath (U.K.); he further conducted several years of postdoctoral research at the University of Bath and at the Università degli Studi di Milano (Italy) successively.      

Αναλυτικό Κόστος Σεμιναρίου

Για Δικαιούχους ΑνΑΔ

  • € 270.00
  • € 160.00
  • € 0.00
  • € 110.00

Για μη-Δικαιούχους ΑνΑΔ

  • € 270.00
  • € 0.00
  • € 51.30
  • € 270.00
ΠΡΟΓΡΑΜΜΑ ΣΕΜΙΝΑΡΙΟΥ

Παρασκευή - 28 Ιουν 2024

Ώρα

09:00 - 15:00

Τοποθεσία:

EIMF (Λευκωσία)

Δευτέρα - 01 Ιουλ 2024

Ώρα

09:00 - 11:45

Τοποθεσία:

OnLine Virtual Classroom

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