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Organisation Description

Pharma Consult brings together International Pharmaceutical Specialists who provide training and consultancy services to major Multinational and National Pharmaceutical companies. PharmaConsult Global Ltd are a training provider of high quality courses based on the latest published technical and regulatory requirements. PharmaConsult approach is to identify the necessary skills, competencies and qualifications needed to perform given roles and to provide an understanding in business requirements and the guidance necessary on functional behaviour to be able to implement best practice standards and ensure patient safety.

CPD Courses and Workshops Available

  • Complying With ICT GCP: The 12 Rules and A Bit More

    Online Course | Pharma Consult

    A practical course, designed to sponsors and investigators as well as their third parties and research staff members. Includes the most common rules to avoid non-compliance, known as the 12 rules. 45 minute online course.

  • Introduction To Pharmaceutical Regulatory Affairs

    Online Course | Pharma Consult

    This module is an introduction to international regulatory requirements for developing, manufacturing and distributing medicines for human use and provides a basis for pharmaceutical regulatory affairs knowledge essential for all staff working in health care and the pharmaceutical industry. 90 minute online course.

  • Introduction To Biotech Good Manufacturing Practices

    Online Course | Pharma Consult

    The course provides an introduction to the international gmp standards required to support manufacturing and inspection activities of biotech manufacturing facilities and drug products. 90 minute online course.

  • Introduction To GMPS

    Online Course | Pharma Consult

    The course provides the historical background to the gmps to provide the necessary understanding of the regulatory authorities? concerns regarding product protection. It will discuss the movement towards harmonizing the gmps in the world?s regulatory markets by discussing the gmps from the US and Europe. Ich q7 will be discussed as a general set of agreed requirements and findings from recent fda inspections will be presented as we understand the reasons for gmps in such a way as to provide a necessary understanding of why we do what we do. 90 minute online course.

  • Introduction To Quality Management Systems (ICH/Pic)

    Online Course | Pharma Consult

    This module provides the latest update (includes amendment to EU gmp guide- February 2014) to assist in implantation of pqms in all aspects of the provision and use medicine to ensure consistency of quality in accordance with the best practice standards guidelines for ich and pic.

  • The Focus Of Pharmacovigilance As An Integrated Risk-Benefit Evaluation

    Online Course | Pharma Consult

    This module will provide an understanding of the scope of pharmacovigilance activities, good vigilance practice, sources of knowledge and main tools for collecting safety information.

  • How Will The New Eu Gdp Regulations Impact On Your Business

    Online Course | Pharma Consult

    This online training is based on the international regulations for Good Distribution Practice (GDP) of pharmaceutical products for human use. It looks into the practices of wholesale distributors and the proper ways and processes concerning the distribution of medicinal products; and roles and responsibilities of all personnel stated in the GDP regulations. It discusses the new EU Guidelines 2013/C 343/01 and measures the impact of the new Falsified Medicines Directive and increasing standards required in a compliant supply chain.

  • Why Do We Need Personalized Medicine?

    Online Course | Pharma Consult

    This module will describe personalized medicine and why it is required. It will provide an overview of current activities in genomics; their translation into new drug discovery and the delivery of personalized medicine.

  • Quality Risk Management Techniques

    Online Course | Pharma Consult

    This course will provide an introduction to the skills and competencies required; to evaluate the impact of out of specification and process deviation by Quality Risk assessment. The candidate will learn how to assess and mitigate risk by using techniques such as Risk cause analysis and failure mode Effect analysis.

  • How to Implement Quality by Design

    Online Course | Pharma Consult

    This course will provide the keys used in Quality by Design; and which will include the development of the API manufacturing process.

  • Regulatory Assessment Requirements of Quality by Design Data

    Online Course | Pharma Consult

    This course will provide the measures necessary to be taken to ensure that the product meets the Quality Target Product Profile and the Regulatory requirements for assessment regardless of the development approach for the areas; API; Formulation; Manufacturing process; Control Strategy; Analytical Procedures and Stability.

  • What you need to know about the new PharmacoVigilance Regulations

    Online Course | Pharma Consult

    An overview about the legal background of Pharmacovigilance regulation; and will review the new regulations for Good Vigilance Practice; the PharmacoVigilance System ; Master file; and the duties & responsibilities of the Qualified person

  • How to survive a PharmacoVigilance Regulatory Inspection

    Online Course | Pharma Consult

    This course gives an overview about the legal background of a Pharmacovigilance Inspection; the preparation of the company in the forefront of the inspection ("inspection readiness") and the procedure of the inspection by the Regularity authority responsibilities of the Qualified person

  • Risk Based Monitoring and Clinical Data Transparency

    Online Course | Pharma Consult

    This course will outline the techniques of RISK BASED MONITORING methodology which describes the steps taken to assess risk; to determine Critical Data and Processes; and to mitigate those risks through the utilization of the Integrated Quality Risk Management Plan (IQRMP)

  • The Basics of Good Clinical Practice

    Workshop | Pharma Consult

    This course is designed for Clinical Operations Staff as well as GCP Auditors and others involved in conducting clinical studies of new medications that require a working knowledge of the regulatory requirements and ICH Regulations for Good Clinical Practices (GCPs).

  • Aseptic Processing for Biopharmaceutical Products

    Online Course | Pharma Consult

    This eLearning lecture provides an overview of the Regulations and Guidelines governing the production of sterile products by aseptic processing and defines the process controls; personal behaviour; cleaning and validation that need to be in place to assure the sterility of the product.

  • Biosafety for Biopharmaceutical Manufacture

    Online Course | Pharma Consult

    This lecture will review the principles of Biosafety in Biopharmaceutical products and will explain the measures taken to provide the assurances that if adventitious agents and known microbiological organisms accidentally or unintentionally contaminate the manufacturing process; then there will be measures in place to contain the contamination and control the level of contamination.

  • Biotech Manufacturing processes to produce Biopharmaceuticals

    Online Course | Pharma Consult

    This course outlines the biotechnological process (biotech) which describes the use of cells or organisms that have been generated or modified by recombinant DNA; hybridoma or other technology APIs that consist of high molecular weight substances; such as proteins and polypeptides.

  • Cell bank characterization for manufacture of Biopharmaceuticals

    Online Course | Pharma Consult

    This course considers the principles for the Characterization and qualification of cell substrates; viral seeds and other biological materials used for the production of Biopharmaceuticals for human use.

  • Stability of Biopharmaceutical Products

    Online Course | Pharma Consult

    This course will outline the requirements for Stability Testing of Biotechnological/Biological products and the distinguishing characteristics to which consideration should be given in any well defined testing program designed to confirm the stability of Biopharmaceutical products during the intended storage period.