Medicinal Chemistry and Therapeutics Training
About This Course
The medicinal chemistry and therapeutics training course is essential knowledge for QPs and those working with pharmaceuticals. This intensive course provides an understanding of the technical terminology, demystifying reference material from patient information leaflets to data sheets.
If you work in the industry, it is vital that you understand the impact of your products on your patients, the good they do and the harm they can cause.
This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.
Key Learning Objectives
On completion of this medicinal chemistry and therapeutics training course, delegates will know and understand:
- How the body works (from cells to key physiology) and what goes wrong
- Major therapeutic areas: central nervous system, heart, respiratory tract, inflammatory disease and gastrointestinal tract
- Drug therapy: receptors, autonomic nervous system and other drug targets
- Cleaning and risk-based cross-contamination avoidance
In addition, there are opportunities to discuss your products with expert tutors from one of the top schools of pharmacy in the UK and hear presentations on currently marketed products.
Course Outline
The Body and How It Works
- Cell structure and function
- Human physiology and body functions
- Introduction to the nervous system
- Introduction to the heart and cardiovascular system
Major Disease States
- Review of disease states that can affect the body:
- Heart
- Respiratory tract
- Inflammatory diseases
- Gastrointestinal tract
- Diseases of the central nervous system
- Cancer
Medicinal Products and How They Affect the Body
- Basis of drug therapy/receptor theory
- The autonomic nervous system
- Classification of medicinal substances by therapeutic area
Other Relevant Issues
- Adulteration and cross-contamination
- Cleaning and cleaning validation
Who Should Attend
The Aspiring Qualified Person
- Our training is generally considered the best available and our QPs are held in high regard within the industry
- As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta
- You are more likely to become a QP with us than with any other training provider
- Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications
The Pharmaceutical Technical Professional
- Not all people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control
- Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development
Course Tutors
Course tutors will be selected from the following:
Chris Prior – University of Strathclyde - Chris is a neuropharmacologist with expertise in neuromuscular function, anesthetic practice and neurological diseases. Having served as Director of Teaching and Assistant Head of Institute in the University’s Institute of Pharmacy and Biomedical Sciences from 2006-2011, he was appointed Academic Vice-Dean within the Faculty of Science from 2011-2015. He currently holds the positions of Senior Teaching Fellow and Associate-Dean.
Gavin Halbert – A pharmacy graduate, QP and professor at the University of Strathclyde, Gavin was appointed as Director of the Department of Pharmaceutics’ Formulation Unit in 1992 with a role to formulate and manufacture anti-cancer drugs accepted by CRUK for use in human clinical trials. Gavin teaches at both the undergraduate and postgraduate level in the areas of pharmaceutics, biopharmaceutics, pharmacokinetics and pharmaceutical microbiology.
He is a co-researcher in the EPSRC Centre for Continuous Manufacturing and Crystallisation and the EU Innovative Medicines Initiative for the Development of Novel Oral Biopharmaceutical Tools (OrBiTo).
Richard Kettlewell – Richard has over 30 years of experience in the pharmaceutical manufacturing sector. He has supported and inspected many sites of varied dosage forms worldwide. Richard has a master’s degree in pharmaceutical sciences and joined the industry in 1986 at GlaxoSmithKline, where he spent 32 years in QC, QA and technical roles. He developed and implemented lifecycle approaches to process validation across R&D and manufacturing organizations and supported new product introductions for both API and secondary filing.
Discounts
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Qualified Person Training With NSF
Watch the video
Good Pharmacovigilance Practice
Cleaning Validation
Pharmaceutical Formulation and Processing
Additional Recommended Courses
CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements
This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many experienced auditors decades to develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. During the course, learners will plan, perform, and report audits based on case studies that simulate internal, supplier, and third-party audits utilizing MDSAP audit criteria. Learners will participate in simulated auditing exercises that include planning and performing audit activities, evaluating audit evidence, and documenting audit findings.
The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).
Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.
By the end of this course you should be able to:
· Describe the purpose of:
- Quality management systems
- Quality management system standards
- Management system audits
- Third-party certification
· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018
· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.
Price: $2800.00
MDSAP Internal Auditor Training
This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.
This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.
An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.
This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
- Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
- Recognize the competency and training requirements for AO auditors
- Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
- Calculate audit time and plan an MDSAP Lite internal audit
- Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
- Identify post-audit MDSAP activities including NC grading
- Recognize the outcomes and goals of an MDSAP audit
Price: $1200.00
EU IVDR Internal Auditor
This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.
This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR). The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.
This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Identify Key Articles and Annexes of the EU IVDR
- Recognize Intent of Requirements as Described in Recitals
- Identify Classification Implementing and Classification Rules
- Identify General Safety and Performance Requirements (GSPRs)
- Recognize Content of Technical Documentation
- Identify Post-Market Surveillance Reporting and Vigilance Obligations
- Recognize one EU IVDR Audit Model
- Plan an EU IVDR Audit
- Document Nonconformities against EU IVDR requirements
Who should attend:
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.
Price: $1200.00