Courses in Reading

...up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure. Numerous exercises are run throughout... Learn about: Identify probable root cause, Document Management, CAPA system...

...This intensive course is intended to evaluate Good Distribution Practice (GDP) as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines... Learn about: Quality Systems, Product marketing, 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: Pharmaceutical manufacturing, Understand data, Manufacturing System...

...interactive and also features several real-life case studies. Course Overview This stimulating course systematically builds up the knowledge of delegates... Learn about: Quality Systems, Goods exportation, Quality Training...

...Understand claim substantiation and product labelling Know how compliance can be enforced The course includes a range of exercises and practical activities... Learn about: Cosmetic Industry Insights, Product Information File requirements, Regulatory Compliance...

...and discusses how these can be removed or managed. Course Overview The packing process is a complex series of operations, often performed at high speeds... Learn about: Quality Assurance, Manufacturing Process, Packaging technologists...

...required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system... Learn about: Pharmaceutical manufacturing, Regulatory Compliance, Quality Testing...

...out in GMP both in the European and USA regulations and guidance documents. The pharmaceutical quality control laboratory serves one of the most important... Learn about: Laboratory Practice, Pharmaceutical manufacturing, Quality Training...

...to inspection observations including addressing any deficiencies raised. Course Overview This course is designed to provide guidance on how to prepare... Learn about: Inspection Process, Inspection Observations, Quality Process...

...technical support, quality control and quality assurance roles. In addition, it will also be of benefit to maintenance and support engineers who are involved... Learn about: Microbiological analysis, Quality Testing, Good Manufacturing Practice (GMP)...

...including management, laboratory and manufacturing staff, and engineering personnel, who need to understand the current GMP expectations of validation... Learn about: Pharmaceutical manufacturing, Equipment qualification, Analytical method 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: Quality Systems, Management Operations, Auditing documentation...

...methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand... Learn about: Contamination risks, Clean room design, Regulatory Compliance...

...what constitutes ‘visually clean’ Be aware of the issues surrounding sampling and testing techniques Appreciate the importance of analytical method validation... Learn about: Good Manufacturing Practice (GMP), Pharmaceutical Plant Cleaning, Sampling and testing techniques...

...and adopts best practice. As such this course provides a step by step explanation of what to do when managing GMP documentation and documentation systems... Learn about: Archiving and retrieval, Quality Management Systems, Regulatory Compliance...

...The course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products. It looks at the legislation and guidance available... Learn about: Testing techniques, Testing results interpretation, Pharmaceutical manufacturing...

...for the Pharmaceutical Quality System? This interactive one day course, which combines tutorials and exercises, enables Senior Managers to discover... Learn about: Regulatory Compliance, Key Performance Indicators (KPIs), Senior Management Responsibilities...

...of internal audits Initiate an audit Create a structured audit programme Conduct an opening and a closing meeting Create a check list of questions to... Learn about: Internal Auditing, Confidence Training, ISO 9001...

...and expectations Understand how ICH Q9 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation Understand... Learn about: Quality Systems, Risk analysis techniques, Good Manufacturing Practice (GMP)...

...it applies to auditing of suppliers Understand how to apply the appropriate standards for auditing pharmaceutical suppliers: PS9000 for packaging components... Learn about: Pharmaceutical Quality Group (PQG), Pharmaceutical manufacturing, Quality Management Systems...