Manufacturing Training Berkshire

...and equipment used Understand the requirements for Good Control Laboratory Practices (GCLP) Produce a report that will satisfy the sponsor organisation... Learn about: Reporting on audits of suppliers, Basic manufacturing techniques, 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: ISO 9001, Quality Training, Key changes...

...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 laboratory administration, Pharmaceutical Research, European Politics...

...recalls are packaging related. This course gives a detailed background into the complicated issues associated with pharmaceutical packaging... Learn about: Packaging Operations, Quality Assurance, Packaging technologists...

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

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

...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: Cleaning validation, Pharmaceutical manufacturing, Equipment qualification...

...into sharp focus the management responsibilities for implementation and assessment of quality systems within an organisation. Most notably the changes... Learn about: Quality Training, Management Operations, Regulatory Compliance...

...important and fundamental issues associated with cleaning validation or verification are broken down and explained. Numerous practical exercises are run throughout... Learn about: Process validation, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...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: Requirements and expectations for QP Sponsors, Pharmaceutical Industry, 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: Archiving and retrieval, Quality Management Systems, Best Practice...

...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, Good Manufacturing Practice (GMP), 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: Clean room design, Quality Testing, Quality Training...

...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: Quality Systems, Good Manufacturing Practice (GMP), Regulatory Guidelines...

...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: Pharmaceutical manufacturing, Quality Training, Internal/External Audits...

...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, Customer Inspections, Inspection Process...

...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: Pharmaceutical manufacturing, GMP update, Legislation and guidelines update...

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

...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: Quality auditing, External auditing, Internal 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: Auditing documentation, Regulatory Compliance, Report Writing...