Quality
GCP Training
Our Organization provides comprehensive Good Clinical Practice (GCP) training services to ensure compliance with FDA regulations for clinical trials of investigational drugs, biologics, and medical devices conducted in the United States. Our services include: On-site GCP training for study teams: We provide on-site training to research staff, including investigators, study coordinators, and other research personnel, to ensure that they have the knowledge and skills needed to conduct a clinical trial in accordance with GCP and FDA regulations. Tailored training: We design our training programs to meet the specific needs of your organization, ensuring that the training is relevant and applicable to your specific clinical trial. Comprehensive training: Our training programs cover all the necessary elements, including International Conference on Harmonization (ICH) guidelines for GCP, FDA regulations for the protection of human subjects in research, institutional review board (IRB) review and approval process, informed consent process, adverse event reporting, data management and record-keeping, and auditing and inspection procedures. Good document practices training: Our training will cover the Good Document Practices which is a requirement in FDA. Refresher trainings: We offer regular refresher training to ensure that your staff stays up to date with the latest regulations and best practices. Certification of completion: We provide certification of completion for each staff member that attended the training program. Our training is delivered by experienced professionals with a deep understanding of GCP, FDA regulations, and the practical aspects of conducting clinical trials. We are dedicated to helping ensure the safety and well-being of human research participants and the quality of the data collected in your clinical trials.
SOP Development FDA Quality compliance
Our consultancy firm specializes in providing services to assist pharmaceutical and medical device companies with compliance to FDA regulations. One key aspect of this is the development of Standard Operating Procedures (SOPs). Our services include: Identification of relevant regulations: We will work with your team to understand the specific regulations that apply to your processes and help you understand the requirements that must be met. SOP development: We will help you develop SOPs that are clear, concise, and easy to understand. Our SOPs will include all necessary steps, inputs, outputs, decision points and critical steps, and any required documentation such as forms and checklists. Review and approval: Our team will review the SOPs and obtain necessary approvals from management. Implementation and training: We will assist with the implementation of SOPs throughout your organization and ensure that staff members are properly trained on the new procedures. Monitoring and corrective action: We will monitor the process to ensure compliance, and assist with the documentation and investigation of any deviations, as well as recommend and implement any necessary corrective actions. Review and update: Our team will review and update SOPs as necessary to ensure they continue to align with current regulations and best practices. Our team is made up of experts who have deep understanding of FDA regulations, best practices, and have experience in quality compliance and SOP development. We work closely with our clients to understand their specific needs and tailor our services to meet those needs.
QSiT Compliance
Our consultancy firm specializes in providing Quality System Inspection Technique (QSIT) compliance services to medical device manufacturers. Our services include: Inspection preparation: We will work with your team to prepare for an FDA inspection by reviewing your quality system documentation and identifying any areas that may need improvement. Inspection support: We will provide on-site support during the FDA inspection, including conducting interviews with personnel and observing manufacturing processes. Inspection report review: After the inspection, we will review the FDA's inspection report and help you understand the findings. Corrective action plan development: If any violations of the QS regulation are found, we will work with you to develop a plan to correct these violations and demonstrate that appropriate corrective and preventative actions have been taken. Follow-up: We will provide guidance and support for any necessary follow-up activities. Our team has experience in FDA regulation and compliance, with deep understanding of the QSIT program, and the Quality System (QS) Regulation, We will work closely with you to ensure your facility is in compliance with the regulations and to minimize the risk of any non-compliances. We also ensure that our services are tailored to meet the specific needs of your organization and can provide ongoing support to help you maintain compliance in the long-term.
