Showing 12556 to 12570 of 21751 results
Pharmacovigilance Audit and Inspections US MasterClass

Pharmacovigilance Audit and Inspections US MasterClass

13 - 15 September, 2022

Online Event

The training will explore the key aspects of pharmacovigilance audits (PV Audits), from planning audit programmes, conducting audits to delivering audit findings through audit reports. The impact of the pv legislation and GVP will be addressed and guidance will be provided. Key Elements: Understand different types of audits. Assessment criteria for auditing. Key principles on audit design and preparation. ...

  • +4 months
Behavioral Good Manufacturing Practices MasterClass

Behavioral Good Manufacturing Practices MasterClass

19 - 20 September, 2022

Online Event

The main goals of this online masterlass are based around improvements in GMP compliance and error reduction. Key elements: Understand the need for cultural change when managing our GMP compliance. Measure the Cost of Compliance in our manufacturing operation. Overview of the bGMP cultural change programme. Understand the different models of human error, human thinking processes and actions. ...

  • +3 months
Clinical Project Management MasterClass

Clinical Project Management MasterClass

26 - 29 September, 2022

Online Event

During these 4 day online masterclass, Trainees will learn how to adapt their project management knowledge to clinical trials.  Key Elements: What are the fundamentals of Project Management? The Project Manager (negotiation, delegation, dealing with clients, quality)? The Project Environment (regulations, guidelines, SOPs) The clinical development Plan. The definition and initiation of a Trial (scope, feasibility, CDP) How...

  • +3 months
Viral Clearance MasterClass

Viral Clearance MasterClass

03 - 04 October, 2022

Online Event

This online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics, how to prevent those risks and how to evaluate the capability of the process to remove and/or inactivate potential viruses through viral clearance studies.  Key Elements: Understand the consequences linked to a contamination of mammalian cell cultures and biologicals Understand the regulatory expectations on prev...

  • +3 months
Advanced CMC MasterClass

Advanced CMC MasterClass

05 - 06 October, 2022

Online Event

This training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex.  Key Elements: Understand the different levels of requirements in CMC during the development and post-approval phase. Overview of stability requirements. Understand what are the Essential Requirements for a Drug Substance. ...

  • +3 months
Implementation of ISO 13485 MasterClass

Implementation of ISO 13485 MasterClass

10 - 11 October, 2022

Online Event

Implementation of ISO 13485 MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation. Key Elements: Medical device quality system requirements and when they apply to medicinal products. Determining whether to implement ISO13485 in the ...

  • +3 months
Advanced Stability Testing of Pharmaceuticals MasterClass

Advanced Stability Testing of Pharmaceuticals MasterClass

10 - 13 October, 2022

Online Event

Advanced Stability Testing of Pharmaceuticals Online MasterClass ill cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life. Key Elements:. The Impact of Thermal Energy and Humidity on Degradation. The opportunities for reduced stability studies. The Smart Selection of...

  • +3 months
Pharma Packaging MasterClass

Pharma Packaging MasterClass

11 - 12 October, 2022

Online Event

This practical training Course's goal is to cover the technical and organisational requirements and procedures of pharma and healthcare packaging and technical operations in a 360-degree coverage. Key Elements: The Requirements of pharma and healthcare packaging. The Global Healthcare and Pharma Market. The concept of the ‘human imperative’ and its practical application. The technical implementatio...

  • +3 months
Quality control for ATMPs and Biologics MasterClass

Quality control for ATMPs and Biologics MasterClass

17 October, 2022 - 17 October, 2022

Online Event

You will learn about quality control requirements for Biologics and Advanced Therapy Medicinal Products (ATMPs). Key Elements: Specifications for Biologics and ATMPs Quality Control for Biologics and ATMPs Visit the official website for more information on the MasterClass: https://glceurope.com/events/pharma/quality-control-for-atmps-and-biologics-masterclass...

  • +2 months