Manufacturing Courses Berkshire

...and equipment used Understand the requirements for Good Control Laboratory Practices (GCLP) Produce a report that will satisfy the sponsor organisation... Learn about: Basic manufacturing techniques, Reporting on audits of suppliers, Enable effective auditing...

...managers to refresh their knowledge and gain an appreciation of the key changes in ISO 9001:2015 vs 2008. Whilst all ISO standards are revised regularly... Learn about: Industry insight, Key changes, ISO 9001...

...to EU GMP and how it is applied in the UK as the Orange Guide Understand the expectations of current good manufacturing practices, and how these can... Learn about: Pharmaceutical Research, Goods importation, Understand data...

...recalls are packaging related. This course gives a detailed background into the complicated issues associated with pharmaceutical packaging... Learn about: Manufacturing Process, Good Manufacturing Practice (GMP), Quality Training...

...and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives... Learn about: Medical Device, Manufacturing Process, Regulatory Compliance...

...their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations. It will be of particular... Learn about: Good Manufacturing Practice (GMP), Identification of non-conformity, Testing techniques...

...The need for effective change management and life-cycle management will be discussed. Suitability The course will be of value to all pharmaceutical professionals... Learn about: Equipment qualification, Cleaning validation, Analytical method validation...

...into sharp focus the management responsibilities for implementation and assessment of quality systems within an organisation. Most notably the changes... Learn about: Auditing documentation, Regulatory Compliance, Pharmaceutical manufacturing...

...important and fundamental issues associated with cleaning validation or verification are broken down and explained. Numerous practical exercises are run throughout... Learn about: Pharmaceutical Plant Cleaning, Pharmaceutical manufacturing, Analytical method validation...

...the challenges that QPs face in industry today. Are you an individual trying to decide whether to make this important career move? Are you a manager considering... Learn about: Pharmaceutical manufacturing, Training Programme, Opportunities for a QP...

...Learning Outcomes At the end of the course you will: Understand the GMP rules and guidelines associated with the preparation, completion and archiving... Learn about: Quality Management Systems, Best Practice for Documentation, GMP Documentation...

...trainee QP’s in mind as they need to ensure they understand the plethora of operations and challenges associated with Pharmaceutical Packaging... Learn about: Printed Packaging Components, Qualified Person (QP), Packaging materials...

...valuable underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products. It will be of benefit to those... Learn about: Sterile Products Manufacture, Regulatory Compliance, Clean room design...

...manufacturing, engineering and validation. The course will be aligned to the latest science and risk based principles and regulatory guidances in the EU and... Learn about: Regulatory Guidelines, Risk analysis techniques, Good Manufacturing Practice (GMP)...

...auditors to converse in the language that is universally used by its suppliers. On successful completion of this course, delegates may apply for professional... Learn about: Quality Management Systems, Regulatory Compliance, ISO 9001...

...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: Inspection Observations, Inspection Process, Customer Inspections...

...are constantly shifting. Since the beginning of 2016, legislation and/or guidelines on the following topics have either been implemented or published for future implementation... Learn about: Quality Management Systems, Industry insights, Regulatory Compliance...

...engineering activities, quality systems and laboratory practices. The course is highly interactive and also features several real-life case studies... Learn about: Goods exportation, Quality Training, Goods importation...

...up knowledge and confidence in GMP. The range of other standards appropriate to external auditing (e.g. GDP, ISO 9001) are described briefly but not explored in depth... Learn about: ISO 9001, ISO 19011, Quality auditing...

...responsible for the release of pharmaceutical products. LEARNING OUTCOMES This course will be assessed and certified by RSSL against the standards of ICH... Learn about: Decision Making, Auditing documentation, Communication Skills...