Training in Berkshire

...Learning Outcomes At the end of the course you will: Understand the regulatory framework of medical device manufacture and marketing Understand the... Learn about: Medical Device, Regulatory Compliance, Quality Testing...

...To demonstrate how to define the Key Phases of the Project Life Cycle. To illustrate the importance of creating an accurate Project Specification...

...calibration, calculations and results. The final session of the course brings all this together by a session on preparing for regulatory inspection... Learn about: Laboratory Practice, Quality Training, Pharmaceutical manufacturing...

...and Generating Reports During the course, you will learn: · Identify the platforms and infrastructure that support CSA and the CSA MC · Describe the CSA...

...for external inspections by customers and regulators, manage an external inspection and respond to inspection observations including addressing any deficiencies raised... Learn about: Quality Process, Customer Inspections, Inspection Process...

...configure, and manage multiple contexts to meet security policy requirements · Select and configure the type of failover that best suits the network topology...

...This course is designed specifically as an introduction to the important topic of pharmaceutical microbiology, it will review the impact of microbiology... Learn about: Quality Testing, Pharmaceutical manufacturing, Quality control...

...To take advantage of this offer, drop us an email after you book your course. Additional info Please note: the cost of the exam is not part of the course...

...management will be discussed. Course Overview The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume... Learn about: Analytical method validation, Regulatory Compliance, Good Manufacturing Practice (GMP)...

...tailoring the case studies around their own specific audit findings, and engaging personnel from different levels within the organisation... Learn about: Auditing documentation, Quality management, Regulatory Compliance...

...an extensive introduction to the regulatory requirements governing pharmaceutical clean room operation, and details the aseptic filling and terminal sterilisation... Learn about: Quality Training, Pharmaceutical Clean Room Operation, Quality Testing...

...execution, or validation of cleaning processes which may include operations managers and personnel, validation specialists, Quality Assurance and Quality Control managers... Learn about: Pharmaceutical manufacturing, Process validation, Quality Training...

...of documentation Appreciate the importance of maintaining a comprehensive documentation system... Learn about: Quality Management Systems, Good Manufacturing Practice (GMP), Pharmaceutical manufacturing...

...monitoring programme appropriate for your operations Know how to interpret results and identify trends... Learn about: Identification of non-conformity, Good Manufacturing Practice (GMP), Environmental Monitoring...

...So how does a Senior Manager actually demonstrate their commitment and support for the Pharmaceutical Quality System? This interactive one day course... Learn about: Continuous Improvement, Pharmaceutical manufacturing, Quality Training...

...Write a non conformity report linked to a GMP change Appreciate the importance of reporting and follow up Know how to behave to avoid conflict and... Learn about: Confidence Training, Internal Auditing, ISO 9001...

...Learning Outcomes At the end of the course you will: Understand the regulatory drivers for QRM, with particular emphasis on European and US requirements... Learn about: Quality Risk Management (QRM), Risk Management, Pharmaceutical manufacturing...

...This modified course focuses on auditing to the ISO 9001 standard and the PQG’s Application Standards for suppliers to the pharmaceutical industry... Learn about: ISO 9001, Quality Management Systems, Pharmaceutical Quality Group (PQG)...

...This course is designed to provide an understanding of why we create errors, how the human brain operates and learns and tools, techniques and approaches... Learn about: Good Manufacturing Practice (GMP), Monitoring Tools, Human Behaviour...

...and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service. It is designed for all those who... Learn about: Regulatory Compliance, Pharmaceutical Industry, Deputy Responsible Person...