A refresher course in Chemistry, applied to the QC Laboratory environment, for pharmaceutical professionals and trainee QPs who haven’t studied Chemistry beyond GCSE level. Designed as a preface to the QP Analysis and Testing Module.
Chemistry is esse
Updated and revised for 2020, this intensive course provides an extensive and detailed introduction to Good Distribution Practices in the Pharmaceutical industry. Covering best practices with practical examples and an overview of the regulatory fram
The Qualified Person relies on the Pharmaceutical Quality System (PQS) to be able to fulfil their legal and operational responsibilities. This course provides a comprehensive overview of the requirements of the UK Study Guide. Scenarios and exercise
This course covers the key concepts of Record and Data Integrity and Electronic Records and Signatures, including the key regulatory requirements and expectations (including Annex 11 and Part 11, and related guidance), example citations, and pragmat
All QPs need to understand the different Good Manufacturing Practice (GMP) requirements for commercial and Investigational Medicinal Products (IMPs), and the unique additional GMP requirements for IMPs. This two day interactive course examines the E
This is a packed day that explores everything involved in becoming a Qualified Person (QP). Attendees are encouraged to ask as many questions as they like to ensure that you leave with a clear understanding and can make an informed decision whether
These online bitesize courses will provide an extensive and detailed introduction to Good Distribution Practices in the Pharmaceutical industry, covering best practices with practical examples.
For those who are new to Good Distribution Practice for
RSSL has been providing Responsible Person training since 2012. Our latest Cogent Gold Standard Approved online and classroom courses incorporate the very latest regulatory aspects, best practice, customer and industry input.
If your organisation alr
Compliance with the forthcoming Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to Medical Device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition sm
This course provides an introduction to the requirements of internal auditing described in the international standard ISO 19011. Frequent opportunities to practice key steps are provided through role play in a no risk environment, with supportive fee
The field of biologically derived medicines is expanding. With an increasing number of products being marketed, biological products bring unique challenges to the manufacturing process.
Biological products have unique challenges and constraints as co
Run in partnership with Environmental Monitoring & Process Validation Specialists, Cherwell Laboratories, the course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products.
It looks at the legislation and gui
Successful completion of this one day course provides the delegate with understanding of the principles of Quality Risk Management (QRM) and its practical application.
The course is focused on ICH Q9 (QRM) and its support to ICH Q8 (Pharmaceutical De
This 5 day fully residential course provides the most comprehensive certification for Lead Auditors in the Pharmaceutical industry. Fully accredited by IRCA and PQG, this is a highly customised Lead Auditor Training course that has been specifically
Updated for 2021 in order to gain RSC Approval, this 3 day course systematically builds up the knowledge of delegates over three intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA.
This interactive course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities. This informative course introduces the EU G
This interactive course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities. This informative course introduces the EU G
It is a regulatory requirement for organisations within the Pharmaceutical and Allied Industries to audit active pharmaceutical ingredient (API) manufacturers, suppliers of key excipients and packaging materials, and contracted-out laboratory service
This course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA) practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP
The QP needs to understand the quality issues associated with the manufacture of biopharmaceuticals. Other modules in the RSSL QP Training Programme are based around the Study Guide, and therefore cover biotechnology products alongside other product
