TRAINING
ScientiaBio has conducted over 40 hands on training in India, Singapore, Malaysia, UAE, South Africa over the last decade. We are currently conducting multiple virtual live training session since the onset of Covid.
We deliver current, relevant training to pharmaceutical, biotech and medical device company to build knowledgeable, compliant workforce. Our training & mentorship on topics ranging from drug discovery to commercialization help each participating companies to learn, develop and evolve. Continuous training leads to effective high performance workforce.
We employ perfect balance of theoretical basis and real world case work in our training.
You can expect :
a. Most engaging instructions
b. Limited class size so all your questions are answered
c. Thought provoking case studies, dynamic discussions and interactive activities so can practice what you have learned.
d. Conducted by instructor who has two to three decades of expertise in the relevant domain
Training Topics
We conduct training on various topics of Clinical Research & Pharmaceutical Quality. Some of our regular topics listed below.
Clinical Research
- Biostatistics
- 1. Applied Statistics for Clinical / Medical Researchers
- 2. Clinical Study Design
- CDISC Data Standard
- 1. SDTM Concepts & Exercises
- 2. ADaM concepts & Exercises
- 3. CDASH Concepts & Excercses
- 4. Define.xml
- Clinical Trial Management & Recruitment Planning
- Clinical Project Management
- Practical Implementation of GCP to achieve Clinical Study Objectives
- New Perspectives of Pharmacovigilance
Pharmaceutical Quality and Regulatory
- GMP Auditor / Lead Auditor Training
- Quality Management Systems
- Deviations, OOS, RCA, CAPA
- CSV Training
- 21 CFR Part 11, GAP Assessment
- Data Integrity Audits
- Current Regulatory Compliance Requirements for Biopharmaceuticals, Biosimilars & Vaccines
Custom Training Courses for you
feedback on our training courses
"Excellent workshop, quite interactive and informative."
"Quite well organized with most relevant info on stats espy for the non-statistician. Fundamentals were touched upon with a lot of clarity and case studies were very helpful."
"Thank you for providing us with a knowledgeable and approachable lecturer. The presentation was comprehensive, informative aspect of pharmacovigilance."
"Examples were relevant to the industry of clinical research. Thoroughly enjoyed this training."
"I enjoyed the workshop very much, the trainer has strong technical knowledge & has great experience in the clinical trial industry so she customized the course properly to fit participants expectations and needs. The trainer conducted the pace of the course appropriately & encouraged the interactions. The exercise also helps us to think if our understanding is correct"
"A great program satisfying an educational need which is not handled by many. I will look at all clinical papers and acquire better insights, Thanks to your program."
"Trainer is a great package of clinical knowledge + SAS + statistics of SDTM, ADaM standards. There is a lot to learn and this training given a deep knowledge of ADaM standards. This will surely help me in my current work and future assignments."
"Training material and the knowledge of the trainer is excellent and outstanding."
"It was really a good and and informative session of two days. In particular case studies and brainstorming sessions were quite helpful to understand all aspects of clinical trial throughly"
"The entire presentation was a very detailed one. The faculty thoroughly explained the concept of Remote Monitoring. The four hour training session was extremely informative and cleared our concepts on the current regulatory requirements regarding remote monitoring."
"Very well explained auditing aspects and GMP elements with real time examples and case study. Tremendous knowledge about the regulatory and statutory requirements. Very good reference/study materials for the course."