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: Enable effective auditing, Reporting on audits of suppliers, Basic manufacturing techniques...

...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: Risk Management, Pharmaceutical manufacturing, Industry insight...

...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, Understand data, Manufacturing System...

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

...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), Testing results interpretation, Pharmaceutical manufacturing...

...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, Pharmaceutical manufacturing...

...into sharp focus the management responsibilities for implementation and assessment of quality systems within an organisation. Most notably the changes... Learn about: Auditing documentation, Quality Training, Quality Systems...

...important and fundamental issues associated with cleaning validation or verification are broken down and explained. Numerous practical exercises are run throughout... Learn about: Analytical method validation, Pharmaceutical Plant Cleaning, Process 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: Good Manufacturing Practice (GMP), Requirements and expectations for QP Sponsors, Pharmaceutical manufacturing...

...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, Good Manufacturing Practice (GMP), Regulatory Compliance...

...trainee QP’s in mind as they need to ensure they understand the plethora of operations and challenges associated with Pharmaceutical Packaging... Learn about: Good Manufacturing Practice (GMP), Quality Systems, 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: Pharmaceutical Clean Room Operation, 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: Pharmaceutical manufacturing, Quality Systems, Risk analysis techniques...

...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: Regulatory Compliance, ISO 9001, Pharmaceutical Quality Group (PQG)...

...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: Pharmaceutical manufacturing, Inspection Observations, 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: Industry insights, Legislation and guidelines update, 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 importation, Quality Systems, Goods exportation...

...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 19011, Confidence Training, 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: Decision Making, Regulatory Compliance, Auditing documentation...