Training in Reading

...when speaking on the telephone. Handle difficult people and situations effectively. Stay calm under pressure. Benefits for the organisation...

...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 Training, Management Operations, Regulatory Compliance...

...the buying process and how clients select suppliers. To show why we need to know the Decision Makers and Buying Influences within your Clients...

...methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand... Learn about: Pharmaceutical Industry, Contamination risks, Pharmaceutical Clean Room Operation...

...execution, or validation of cleaning processes which may include operations managers and personnel, validation specialists, Quality Assurance and Quality Control managers... Learn about: Sampling and testing techniques, Pharmaceutical manufacturing, Good Manufacturing Practice (GMP)...

...Documentation is the cornerstone of any company’s quality management system and is an essential GMP requirement. It is critical that anyone dealing with... Learn about: Best Practice, Good Manufacturing Practice (GMP), Best Practice for Documentation...

...monitoring programme appropriate for your operations Know how to interpret results and identify trends... Learn about: Testing results interpretation, Testing techniques, Good Manufacturing Practice (GMP)...

...So how does a Senior Manager actually demonstrate their commitment and support for the Pharmaceutical Quality System? This interactive one day course... Learn about: Regulatory Inspections, Regulatory Compliance, Pharmaceutical Quality System (PQS)...

...GDP, ISO 9001) are described briefly but not explored in depth. Course Overview This course provides an introduction to the requirements of internal auditing... Learn about: Good Manufacturing Practice (GMP), Internal Auditing, Confidence Training...

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

...materials to the pharmaceutical industry. ISO 9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that... Learn about: Good Manufacturing Practice (GMP) standards, Regulatory Compliance, Quality Training...

...Influencing factors that create human errors Be aware of error situation traps Understand the difference between errors and violations Utilise basic tools... Learn about: Learning Processes, Monitoring Tools, Problem Solving...

...to understand the key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence. Learning Outcomes The course... Learn about: Good Manufacturing Practice (GMP), Quality Systems, Responsible Person (RP)...

...and Deputy RP in the light of the extensive requirements included in the MHRA Orange/Green Guides in relation to current Good Distribution Practice (GDP)... Learn about: Good Manufacturing Practice (GMP), Deputy Responsible Person, Good Distribution Practice (GDP) Guidlines...

...Revisions to EU GMPs mean that the responsibilities of the Qualified Person regarding Active Pharmaceuticals are wider than ever. These include formally... Learn about: Manufacturing API's, Control of Packaging Materials, Process and Cleaning Validation...

...Course Overview Qualified Persons cannot fulfil their role in a responsible way unless they understand the actions and uses of the medicinal products manufactured... Learn about: Pharmaceutical manufacturing, Pharmacokinetics and Pharmacodynamics, Qualified Person (QP)...

...The Qualified Person must understand the derivation and application of the data with which they will be presented. This course focuses on the practical... Learn about: Pharmaceutical manufacturing, Data analysis, Quality Assurance...

...information on how to improve the control of packing operations... Learn about: Good Manufacturing Practice (GMP), Packaging materials, Pharmaceutical manufacturing...

...the QP needs a good understanding of the microbiological control of pharmaceutical products, production environments and people. This course will cover... Learn about: Good Manufacturing Practice (GMP), Sterile and non-sterile products, Interpretation of Microbiological Data...

...be part of a comprehensive ‘Pharmaceutical Quality System’, including QA and GMP, and it must be correctly implemented and controlled. This module reviews... Learn about: Quality Control Laboratory Testing, Analytical Chemistry, Pharmaceutical manufacturing...