Reading scientific Services Limited courses

...The QP needs to understand the quality issues associated with the manufacture of biopharmaceuticals. Other modules in the RSSL QP Training Programme... Learn about: Regulatory Compliance, Contamination risks, Problem Solving...

...is designed to ensure a common framework for all ISO management systems. The changes in the new ISO 9001:2015 go further than structure, however... Learn about: Good Manufacturing Practice (GMP) standards, ISO 9001, Key changes...

...create a check list of questions to ask • Be able to identify non conformities against ICH Q7 and regulatory expectations • Be able to identify product... Learn about: Decision Making, Problem Solving, Report Writing...

...Quality management systems for Medical Devices ISO 15378 - Primary Packaging Materials... Learn about: Quality Training, IT Auditing, Quality management...

...Data Integrity is assuming greater importance in cGMP, with both the FDA and European Regulatory Agencies placing a high degree of focus on the subject... Learn about: Control instrument inspection, Process Control, Identify the data lifecycle elements...

...Participants find that it helps them to use their time efficiently, organise their thinking, plan the content of their documents, target the intended readership... Learn about: Communication and interpersonal skills, Report preparation, Report editing...

...and reactive situations Understand tools and techniques that can be used in FI to identify probable root cause Understand the requirements of a CAPA system... Learn about: Document Management, Identify probable root cause, IT risk...

...as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2003/C343/01 and... Learn about: Products Retail, Quality Systems, Product Analysis...

...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... Learn about: Understand data, Manufacturing Technology, Pharmaceutical manufacturing...

...Other sessions examine manufacturing, packaging, premises, equipment, engineering activities, quality systems and laboratory practices. The course is highly... Learn about: Quality Training, Goods exportation, Quality Systems...

...from the old Cosmetics Directive. Note: There are a number of aspects of the Regulation that are under review and the course tutors will endeavour to... Learn about: Cosmetic ingredients, Cosmetics Regulations, Product Information File requirements...

...adequate controls are in place for such operations... Learn about: Quality Assurance, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...standards and how they are used in the approval process Have knowledge of the tools used in risk assessment and vigilance systems... Learn about: Regulatory Compliance, Quality Testing, Medical Device...

...the unique role of testing laboratories in the pharmaceutical environment Be able to prepare for regulatory or customer audits... Learn about: Pharmaceutical manufacturing, Quality Training, Laboratory Practice...

...This course is designed to provide guidance on how to prepare for external inspections by customers and regulators, manage an external inspection and respond... Learn about: Quality Process, Pharmaceutical manufacturing, Regulatory Compliance...

...Understand what checks and tests can be performed to help manage microbiological issues... Learn about: Microbiological analysis, Good Manufacturing Practice (GMP), Quality Testing...

...verification, qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation... Learn about: Equipment qualification, Pharmaceutical manufacturing, Cleaning validation...

...the importance of ownership to ensure compliance Realise the benefits of effecting a ‘quality culture’ As a public programme the course uses hypothetical... Learn about: Auditing documentation, Regulatory Compliance, Quality Systems...

...and terminal sterilisation methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient... Learn about: Sterile Products Manufacture, Quality Testing, Good Manufacturing Practice (GMP)...

...to the overall objectives, the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course... Learn about: Good Manufacturing Practice (GMP), Analytical method validation, Pharmaceutical manufacturing...