Hands-on Training on Product Validation and Quality Control
Like all other pharmaceutical products, biopharmaceutical APIs and finished products undergo rigorous quality control in order to confirm conformance to pre-determined specifications. Products must be tested for identity, impurities, quantity, e.g., protein content and stability to ensure safety and efficacy of the biopharmaceutical products. Thorough quality control is also required by all GMP regulations and is frequently subject to regulatory inspections. Because of higher complexity, the analysis of biotechnology derived products involves more sophisticated analytical procedures.
The workshop will give a comprehensive overview of different analytical techniques used in biopharmaceutical quality control laboratories; workflow for product characterization profile; specifications and acceptance criteria.
In addition, product validation including reliable solution for identifying product degradation and monitoring them throughout production and also comprehensive portfolio of solutions for determining impurities such as host cell, metals and residual solvents would also be covered. Programme shall be conducted by trainers and faculty from Agilent Technologies, KIIT-Technology Business Incubator and other leading organizations.
| Day 1 | ||||
| Topic | Details | |||
| Solve any analytical challenge: Mass Spectrometry and its various applications | Introduction to Mass spectrometry; Different types of Mass spectrometers, working principle with special focus on QTOF, advances in mass spectrometry and its application, Understanding of important mass spec terminologies | |||
| Comprehensive LC/MS and GC/MS based tools for metabolomics studies | The talk shall emphasize on discovery and targeted metabolomics workflows and its applications; databases and how to conduct searches (practical) as well as the talk shall emphasize on GC based metabolomics approach in various applications as well as how it can complement LC/MS (Practical). | |||
| Day 2 | ||||
| Gain a new perspective with rapid measurement of metabolic functions in live cells using Seahorse XF Analyzers | The talk shall showcase how Seahorse can complement LCMS | |||
| Characterization of intact proteins | The talk shall emphasize on Agilent Biopharma workflow from sample preparation to data analysis (Practical) | |||
| Achieve better reproducibility and higher recovery rates of your protein sample:AssayMAP Bravo | The talk shall emphasize on the functionality of AssayMap and its applications | |||
| Day 3 | ||||
| Product Validation, PTM and degradation analysis | Reliable solution for identifying degradation product and monitoring them throughout production | |||
| Host cell and process related impurities analysis | Comprehensive portfolio of solutions for determining impurities such as host cell, metals and residual solvents. | |||
| Day 4 | ||||
| Advanced analytical solutions for Molecular and Atomic Spectroscopy | The talk shall emphasize on spectroscopy NPIs | |||
| Analysis of trace materials in complex samples- all within a single analysis | The talk shall emphasize on ICP-MS and its utility in screening for target compounds in complex matrices (Practical) | |||
| Day 5 | ||||
| GeneSpring and advanced statistical software tools | The topic will cover MPP, GeneSpring, Pathway Architect (introduction and hands-on) | |||
Practical training shall be covered by trainers from Agilent Technologies.
- Dr. Utpal Tatu, IISc Bangalore
- Dr. Tapas Chakraborty, IACS Kolkata
- Dr. Koel Chaudhury, IIT Kharagpur
- Dr. Sibaprasad Sahoo, PI Industries, Udaipur
- Dr. B M Rao, DRL, Hyderabad
During this workshop, participants shall learn about:
- Mass Spectrometry and its various applications
- Comprehensive LC/MS based tools for discovery and targeted metabolomics
- Comprehensive GC/MS based tools for metabolomics studies
- Characterization of intact proteins
- Advanced analytical solutions for Molecular and Atomic Spectroscopy
- Analysis of trace materials in complex samples- all within a single analysis
- Product Validation, PTM and degradation analysis
- Host cell and process related impurities analysis
- GeneSpring and advanced statistical software tools.
At the end of this programme, the participants shall be able to:
- Importance and Value of Regulations and Quality Assurance
- Analytical procedures for a complete set of specifications for pharmaceutical product.
- Strategies for Product Validation
- Methodology and analytical instrumentation for structural characterization and confirmation.
Interested personnel from the Industry, Research Institutions, Academic Institutions, Government Bodies, etc. who have a minimum academic qualification of B.Tech/Masters in area of science and technology and atleast 2 years of work experience are eligible to apply for the programme. Applications from non-working professionals who have completed their post graduate/doctorate degree in areas of science and technology can apply for the programme. There is an upper age limit which is 45 years to apply for the programme. Only those applicants with relevant background and expertise in the area of training are encouraged to apply for the programme.
In order to apply for the programme, please click on the ‘Apply Now’ button. Application form comprises of questions related to participant profile, academic qualifications, work experience, achievements, etc. As part of the application, following is required to be submitted along with the application –
- Date of birth proof ID (Driver’s License, Aadhar, PAN Card, Passport)
- Endorsement Letter from head of department/organization (For working professionals)
- Certificate of highest academic qualification
- Screenshot of online payment
In case of inability to upload document along with the application form, please check the size of the document. The permissible limit of each document is 1 MB.
A nominal amount of refundable commitment fee of Rs. 1,500/- shall be charged from applicants to ensure only serious candidates applies for this programme. The amount shall be refund to the non-selected applicants and selected applicants after the training programme. Fees shall not be refunded to the candidate who have confirmed their participation and not attending the programme for the entire duration of the workshop. The fees need to be paid as part of the application form using a safe and secure integrated payment gateway. Please mention your bank account details in the application form in order to refund the fees. Processing fees of about 2.6% shall be deducted while refunding the commitment fees to the applicants.
Suitable candidates shall be selected based on eligibility criteria and merit of their application. Applications found to be incomplete and ineligible shall not be shortlisted for training. Candidates shall be informed of their selection or non-selection by email. Selected participants shall confirm their participant to BCIL. In case the selected participant shall be unavailable to attend the programme after confirmation, he/she shall inform BCIL. Selected participant cannot nominate another colleague/friend from their organization.
For the out-station participants, accommodation and hospitality arrangements shall be available for the duration of the programme. Conveyance shall be provided from the accommodation facility to the programme venue. Please note that the participant shall make his/her own travel arrangements to reach the venue of the workshop/accommodation. No travel allowance shall be given to the participant.
Participant shall have to attend the full 5 - day programme. Certificate of participation shall be awarded to the participant on successful completing the entire duration of the training programme.
You may kindly contact [email protected] or 011-23219064-67 for any further queries regarding the programme.
