Reading scientific Services Limited courses

...are and the controls to minimise the risks, including viral and TSE control strategies Understand quality systems for biopharmaceuticals Have an insight... Learn about: Biotechnology Issues, Problem Solving, Qualified Person (QP)...

...Whilst all ISO standards are revised regularly to keep up to date with the marketplace, the new high level structure (HLS, based on Annex... Learn about: Good Manufacturing Practice (GMP) standards, Risk Management, Pharmaceutical manufacturing...

...The course is focused on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe. COURSE OVERVIEW... Learn about: Auditing documentation, Problem Solving, Decision Making...

...(Quality Management Systems) are explored in detail. Learning Outcomes By the end of the course you will be able to understand the structure and key requirements... Learn about: Quality Training, Quality management, IT Auditing...

...falsification or fraud Be able to identify the data lifecycle elements for both manual (paper) and electronic data Understand the potential risks and weaknesses... Learn about: Understand data, Identify the data lifecycle elements, Control instrument inspection...

...in your organisation to the structures discussed in the course Have some guidelines for checking that your writing is readable and consistent Know... Learn about: Target markets, Report writing for Management, Writing clearlly...

...of the course you will be able to: Understand the regulatory background to FI and CAPA Understand risk analysis Understand the use of FI in both prospective... Learn about: IT risk, Company policy and procedure, Identify probable root cause...

...up and implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products. It reviews GMP/GDP supply chain integrity... Learn about: Products Retail, Quality Systems, Product Analysis...

...in the essentials of pharmaceutical GMP. Learning Outcomes By the end of the course you will be able to: Find your way confidently around the EU Guide... Learn about: Pharmaceutical manufacturing, Understand data, Manufacturing System...

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

...An in-depth, interactive course which gives delegates a full overview and understanding of the cosmetics regulations in the EU, and what you need to know to market a product... Learn about: Claim substantiation and product labelling, Cosmetics Manufacture, Cosmetics Regulations...

...line detection/rejection systems, the majority of pharmaceutical quality complaints and recalls are packaging related. This course gives a detailed background... Learn about: Pharmaceutical manufacturing, Quality Training, Quality Assurance...

...Course Overview This interactive Good Manufacturing Practice (GMP) training course covers the requirements of the Medical Device Regulatory Standard... Learn about: Regulatory Compliance, Pharmaceutical manufacturing, Quality Testing...

...calibration, calculations and results. The final session of the course brings all this together by a session on preparing for regulatory inspection. Course... Learn about: Quality Training, Laboratory Practice, Pharmaceutical manufacturing...

...Understand how to prepare for inspection Be familiar with key roles, and responsibilities Understand how to host an external inspection Understand... Learn about: Regulatory Compliance, Pharmaceutical manufacturing, Customer Inspections...

...Understand what checks and tests can be performed to help manage microbiological issues... Learn about: Quality Testing, Pharmaceutical manufacturing, Quality control...

...The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (validation... Learn about: Cleaning validation, Good Manufacturing Practice (GMP), Regulatory Compliance...

...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: Quality Systems, Auditing documentation, Pharmaceutical manufacturing...

...methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand... Learn about: Good Manufacturing Practice (GMP), Contamination risks, Quality Testing...

...production engineers, microbiologists, quality systems auditors and supplier auditors. Learning Outcomes At the end of the course you will: Appreciate... Learn about: Quality Training, Good Manufacturing Practice (GMP), Process validation...