Clinical Research
Tips and Tricks of effective GCP Audit
Why this training?
Whether you represent investigatory sites, or sponsor or CRO sites, it’s important to prepare for GCP inspection beforehand. Understanding how GCP audits and inspections are performed can make the process easier. Anyone who aspires to be in Clinical Trials Or is already part of the industry Or If you will be hosting an audit soon Or If you are curious to learn more about Audits and how they are conducted. Join this training and you will learn from basic to expert tips on how to face an audit and what are the common findings that you can avoid!!
Date : 1st, 2nd and 3rd February, 2024
Time : 5pm to 7pm IST on 1st February (Friday) (11.30am to 1.30pm London time / 7.30pm to 10pm Singapore time)
11am to 1.15pm IST on 2nd February (Saturday) (5.30am to 7.45am London time / 1.30pm to 3.45pm Singapore time)
11am to 1.45pm IST on 3rd February ( Sunday) (5.30am to 8.15am London time / 1.30pm to 4.15pm Singapore time)
Duration : 7 hours
Mode of training : Online LIVE (Using zoom platform)
Course Fee : 275 USD ( for participants registering from outside India)
9500 INR (for participants registering from India)
( including complete training material and certificate)
*Register on or before 31st December, 2023 get 10% discount
Course Agenda :
Day 1 :Audit - Purpose, Preparation & common observations - 2 hrs
What is Audit and Its purpose
Preparation
Common observations from Audit and Inspections with data from USFDA and case studies
Day 2 : Conduct of Audit, tricks and Tips during Audit - 2 hrs 15 mins
How Audit is conducted - 30 mins
Tips and Tricks for Audit Hosting - 30 mins
Common observations and mistakes during Audit with case studies - 1 hr
Day 3 - Audit closure and CAPA - 2 hr 45 mins
How to draft SMART CAPA
Good and Bad CAPA with examples
Exercise to draft CAPA - 45 mins
Trainer's Profile : Akansha Jain
Akansha is a skilled professional with 15 years of experience in Clinical Research. Previously she had worked with Astra Zeneca as Clinical Quality director. Before that she had worked with IQIVA as senior auditor, quality assurance.
She has experience of working at CRO, Sponsor and Site Management Organization. Varied exposure of working in several therapeutic areas with all phases in clinical trial (including Phase II, III, IV and observational trials). Few e.g. are as follows - Pediatric Epilepsy, Bipolar Disorder, DengueVaccine, Gastroenteritis, Schizophrenia, Diabetic Painful Neuropathy, Diabetes Mellitus Type I and II, Allergic Rhinitis, Asthma, Asthma, Device Implant, CNVM – Ophthalmology, Cardiovascular and Oncology.
She has Experienced clinical research with experience in performing Audits and Quality Management visits at investigator site (remote and physical) and vendors. She has performed over 100 Audit at sites including process & system audits and Vendor Audits. She has performed Internal Process & System Audits for Clinical operations, eTMF, Data Management, Bio-statsteam, and medical writing.
She also has conducted Root Cause Analysis and closed CAPA for the Inspections (USFDA, Health Canada andEMEA) She has managed more than 400 CAPAs for audits and inspections and over 300 Quality Issues globally. She is also an expert in delivering training on Audits and inspections and on GCP/regulatory requirements to the Employees, Investigators and Ethics Committees.
Please send your registration details ( Name, Company Name, Designation, Contact no and email id ) to admin@scientiabio.com / scientiabio@gmail.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.
Click on www.scientiabio.com to know more about our consulting and training services.
Past Training
Effective Strategies for Successful Remote Monitoring of Clinical Studies
Why this training?
It has been just over 2 years since novel coronavirus came & disrupted our lives. Interestingly disruption fuelled many new strategies to do conventional work remotely. Although remote monitoring of clinical trial existed in theory for many years now, but its become a adopted practice by many sponsors, CRO after the onset of coronavirus. Moving forward, we will see remote monitoring as a part of successful strategy for managing clinical trials. This training will focus on different tips and strategies of successful remote munitioning of clinical trials.
Date : 16th to 19th August, 2022
Time : 5.30pm to 7.30pm IST ( 1pm to 3pm London Time / 8am to 10am EST)
Duration : 8 hours
Mode of training : Online LIVE (Using Teams platform)
Course Fee : 250 USD ( for participants registering from outside India)
8000 INR (for participants registering from India)
( including complete training material and certificate)
Course Agenda :
Day1
Fundamentals of De-centralized Trials
Day 2 & Day 3
Risk based remote monitoring planning & implementation
Day 4
Technologies for virtual risk based monitoring and De-centralized trials
Q & A session
Training will focus on group discussion, case studies etc.
Trainer's Profile : Bhumi Vyas
Bhumi Vyas is a qualified QA professional with 17 + years of experience in the field of Pharmaceutical, Biotechnology & Clinical Research industry making a difference in the organizations by initiating the new era of linking technology with research science.
Significant & Successful track record in establishing & implementing Quality Management System. Having wide range of experience in performing and managing clinical & analytical audit program and ensuring compliance to US FDA Code of Federal Regulations (CFR), EU, ICH GCP and global regulatory requirements. In depth analysis with solutions of CAPA systems, investigations & root cause analysis.
Successfully handled regulatory inspections (and has lead inspection readiness program) from DCGI – India, UK MHRA, US FDA, EMA, Thailand-MoH, Turkey-MoH, ANVISA – Brazil, WHO, MCC – South Africa and Kazakhstan – MoH.
Past Training Feedback on the same topic :
"It was excellent session and useful information’s" - Badriyah, King Abdullah International Medical Research Center (KAIMRC), Saudi Arabia
"The entire presentation was a very detailed one. The faculty thoroughly explained the concept of Remote Monitoring. The training session was extremely informative and cleared our concepts on the current regulatory requirements regarding remote monitoring."- Ambika, Biocon Biologics
"Overall the training was efficient, informative and useful." - Rita, MCT, Lebanon
Please send your registration details ( Name, Company Name, Designation, Contact no and email id ) to admin@scientiabio.com / scientiabio@gmail.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.
Click on www.scientiabio.com to know more about our consulting and training services.
GCP: Project Management during these challenging period
Project management is crucial for success of any research projects and especially when they are in healthcare. Managing the projects within the framework of guidelines, regulations and compliance needs meticulous planning and through understanding. The challenges are many and current worldwide situation is test of our skills and knowledge. New insights with changing times always help. Get yourself ready for the new NORMAL of the project management.
This training will help you assess understanding the crucial issues, the roles and responsibilities and the effectiveness of the monitoring process. It will help you devise new strategies for remote monitoring with identifying and flagging the key areas for corrective measures. Afterall, each step is important and must be executed meticulously.
Date : 28th, 29th and 30th September, 2020
Duration : 7.5 hours
Time : 5 pm to 7.30 pm IST (7.30am to 10am Eastern time)
Mode of training : Online LIVE (Using Zoom platform)
Course Fee : 95 USD or 6500 INR ( including complete training material and certificate)
Course Content :
Key aspects of project management as per GCP
2. Challenges in conducting clinical trials
3. Emerging additional challenges during the pandemic and lock-downs
4. Identifying the key problem areas
5. Finding innovative solutions
6. Tools for effectiveness
7. Key learnings
8. Conclusions
Trainer's Profile : Dr. Manjusha Rajarshi, Ph.D
Dr Manjusha Rajarshi has got more than 25 years of working experience in the pharmaceutical industry. She was working with multiple pharma companies in the past like Serdia, Bayer, Aventis Pasteur, Unichem, B. Braun. She had adopted multiple roles in the past, her career moved from training department to medical department to clinical operations and regulatory affairs and medical affairs.
Dr Majusha holds master degree in pharmaceutical science from University of Mumbai and PhD in Pharmacology from University of A.M. Kolkata. She has more than 25 publications in various journals like American Journal of Cardiovascular Drugs, Neurology, International Journal of Cardiology, Diabetes Research etc. She is now a consultant & trainer in the area of regulatory affairs, clinical research, Medical writing, audits and compliance.
Feedback of previous same training :
All went well. learned a lot and the course met my expectation" - Olebogeng Jokane; Project Manager, The Aurum Institute
"Presenter was subject matter expert. Examples were relevant to the industry of clinical research. Throughly enjoyed this training."- Giuseppe de Gouveia, Clinical Operation manager, University of Cape Town
"Very high standard. Really helped with equipping me to manage project better going forward. Helped to identify weak links and how to improve. Looking forward to going back to work and implementing."- Dr Sharon Booysen, Medical Officer-Sub Investigator, Perinatal HIV Research Unit
"Presentation was well planned and the faculty have ensured that participants are all actively involved."- Selomang Malepe, CRA, PRA International
Topic : Remote Monitoring during clinical trial : a risk based approach
With the global COVID-19 pandemic, sponsors and sites are faced with circumstances that may slow clinical research. Travel restrictions have made it difficult for subjects to get to sites for their study visits. CRAs too are unable to conduct onsite monitoring visits. As a result, sponsors are exploring remote monitoring solutions.
This course looks at implementing the shift from traditional monitoring to remote monitoring and how these visits may be conducted in the changing environment. It includes reassessing ways to collaborate virtually with sites and completing the report.
Date : 21st and 22nd July, 20 20
Duration : 4 hours
Time : 6 pm to 8pm IST (8.30am to 10.30am Eastern time)
Mode of training : Online LIVE
Course Fee : 45 USD or 3000 INR ( including complete training material and certificate)
Course Content:
1. Introduction to Remote Monitoring
2. Planning a Remote Monitoring Visit
3. Conducting a Remote Monitoring Visit
4. Report and Follow-up
Trainer's Profile :
Suheila Abdul-Karrim
Suheila Abdul-Karrim is an independent clinical research consultant providing services & training to Pharma, CRO and Medical Institute. Based in Johannesburg, she has got over 21 years of clinical trial experience as clinical research manager, GCP trainer & auditor. She is currently the Vice-Chair of ACRP Professional Development Committee. She travels extensively to Africa, Asia, India, USA & Europe for training & auditing activities.
Please send the filled up registration form to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.