Training Overview

QA and Risk Management approaches when managing clinical trials online course Instructor Michael discusses applying risk-based decision making to ensure the long-term impacts of your company’s current decisions are fully understood. He covers:

Conducting Clinical Research is a complex process and involves balancing Costs, Time, and Risks to ensure that the drug(s) under investigation can be proven to be safe and effective, and that the relevant Regulatory Authorities are provided with the data to confirm this.

 Managing Risks in all aspects of the data collection process is a key to meeting the aforementioned objective, and with the changing landscape of the Clinical Trial environment, each QA function should play a key role in Risk Management activities, working with the relevant Clinical Development teams and providing input, as and when needed.

 This presentation focuses on the role of QA in the Risk Management process when deciding on how data should be collected and ensuring the sources of the data are acceptable quality to meet the required company and regulatory standards.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Webinar Takeaway

  • Outline the role of QA in Risk Management
  • Risk Management methods and tools 
  • Methods used to measure the overall quality of Clinical Trial data 
  • Identify and manage risks of clinical trials
  • Ways to integrate quality risk management (QRM) into your quality systems, such as change control and investigations, and how integration can benefit your organization;
  • Risk management tools available to you to meet regulatory requirements
  • Recognizing the critical QRM regulations that apply to Pharma.

Who Will Benefit

  • Auditors
  • QA/QC Personnel
  • R&D Management
  • Compliance Officers
  • Executive Management
  • Laboratory Management
  • Risk Management Specialists
  • Regulatory/legislative Professionals
  • Manufacturing Directors and Supervisors
  • Validation Specialists, Scientists

Michael Ramcharan

Course Instructor

Greater Guildford Area, United Kingdom

Michael Ramcharan has 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations (CRO) mainly in the GCP and GPV areas. He has conducted a wide variety of audits (both On-site and Remote) globally, and managed various risk-based audit programmes. He has also hosted and supported many European Regulatory Authority Inspections (eg; MHRA, EMA, Local EU country Inspectorates).

Michael’s audit experience has also extended to successfully designing and implementing various audit and Training programmes, and for providing general Quality Management System support. He is currently a member of the Pharmaceutical Information and Pharmacovigilance Association (PIPA), Research Quality Assurance (RQA), and an active committee member of the RQA South West, UK Regional forum group.

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Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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