Continuous Professional Development Courses in Upstream and Downstream Biologics and Pharmaceutical Manufacturing
Efficient training of personnel at all levels is vital for maintaining a profitable operation and meeting the requirements of regulatory authorities.
Gaps in employee and contractor training remain one of the top reasons drug manufacturers fail cGMP compliance inspections by regulatory authorities.1 Operator error causes more batch failures at the commercial (3.2%) and clinical (4.3%) scale.2
At Pall, we have redesigned our course delivery to add flexibility and provide rapid knowledge transfer in a scalable manner that suits individual trainee requirements.
TRAINING FEATURES AND BENEFITS
- Courses designed and led by experts in biopharmaceutical filtration applications.
- Each course is customized to ensure maximum relevance to each trainee's operation.
- Well-equipped laboratories for hands-on training
- Post-training troubleshooting assistance for trainees in their field of work
- Real time assessments utilizing interactive and engaging audience response
- A certificate of course completion is provided for attendees who pass the evaluation.
*Discounted pricing available for minimum 10 no. of participants from the same organization.
More training programs to come soon - Register Now
References
- Top 10 GMP Audit Failure Reasons: FDA and TGA Inspection Findings - https://www.onlinegmptraining.com/top-10-gmp-audit-failure-reasons-fda-tga/, accessed October 7, 2021.
- 18th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, A Study of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates, Inc.
Training Available
Introduction to Integrity Testing
Introduction to Direct Flow Filtration
Introduction to Tangential Flow Filtration
Introduction to Cell Culture
Introduction to Integrity Testing
Location
Pall’s training facility in India / Microsoft Teams
Duration
Two days for face-to-face training / 8 hours for virtual training (split into 4 hours each for two days)
About the Course
Filters used in pharmaceutical processes require validation in accordance with Good Manufacturing Practice (GMP), as such they must be routinely tested for integrity. The need to comply with regulatory authorities and provide assurance of patient safety when manufacturing drug substances has, over time, increasingly progressed filter integrity testing into a high place of significance.
Who should attend:
Operators, supervisors, and managers who require a working knowledge of filter integrity testing.
Course Objectives
Attendees will be able to:-
- Describe filter integrity test principles and the factors that could impact test results.
- Replicate the steps when performing an integrity test
- Understand how to recognize and troubleshoot commonly seen false errors and interpret test error messages.
- Gain practical experience on filter integrity test methods by operating manual and automatic integrity test devices
Course Content
- Destructive versus non-destructive tests
- Principles of filter integrity tests
- Factors impacting filter integrity tests
- Regulatory expectations
- Analyze results and define actions in case of non-conformance (troubleshooting)
- Operating manual and automated test devices
Introduction to Direct Flow Filtration
Location
Pall’s training facility in India / Microsoft Teams
Duration
One day for face-to-face training / 6 hours for Virtual training (split into 3 hours each for two days)
About the Course
Liquid and air filtration plays a critical role in contaminant removal at many points in the biopharmaceutical and pharmaceutical production process, ultimately ensuring safety and sterility of the final drug product. From upstream growth media through downstream buffer additions to final formulation and filling, correct filter selection and validation drives efficiencies in processing while providing confidence in achieving drug critical quality attributes (CQAs).
Who should attend:
Operators, supervisors, and managers who require a knowledge of direct flow filters, filter selection and scale-up.
Course Objectives
Attendees will be able to:
- Explain direct flow filtration
- Understand factors impacting direct flow filtration
- Gain understanding of the filter media structure and their retention mechanism
- Choose the right filter for the application and scale-up
- Gain practical experience in filter sizing studies
- Correlate filter integrity test and filter performance
Course Content
- Introduction to filtration
- Filter media types and how filters work
- Filter construction and installation
- Types of filters
- Process control and scale-up
- Integrity testing
Introduction to Tangential Flow Filtration
Location
Pall’s training facility in India / Microsoft Teams
Duration
One day for face-to-face training / 6 hours for Virtual training (split into 3 hours each for two days)
About the Course
Tangential Flow Filtration (TFF), also called Cross Flow Filtration (CFF), is a rapid and efficient method for filtration and separation of solutions containing biomolecules, or particles such as viruses, bacteria or cellular material. It is a process whereby product flow (feed) is directed tangentially along the surface of a membrane with most of the solution circulated back to the feed tank. Microfiltration and ultrafiltration processes incorporating tangential flow or cross flow filtration is utilized in a wide range of biopharmaceutical applications.
Who should attend:
Operators, supervisors, and managers who require a working knowledge of tangential flow filters, critical operating parameters and scale-up.
Course Objectives
Learners will be able to:
- Explain tangential flow filtration
- Understand factors impacting tangential flow filtration
- Gain understanding of critical operating parameters and their impact
- Choose the right filter for the application and scale-up
Course Content
- What is TFF?
- TFF basics/application
- TFF membrane configurations
- Key operating parameters for microfiltration and ultrafiltration / diafiltration
- TFF operation – Set up
- Scaling up
- Cleaning, flushing, Normalized Water Permeability (NWP) and storage step
- Single-use TFF
Introduction to Cell Culture
Location
Pall’s training facility in India / Microsoft Teams
Duration
4 hours for face-to-face training / 2 hours for Virtual training
About the Course
What does it take to get a new biotech drug to market? The process development starts with culturing cells and requires the right technology to produce them reliably and efficiently. In addition, a capability to seamlessly move out of process development, into clinical trials, and from small to large-scale cGMP manufacturing, is essential.
Who should attend:
Operators, supervisors, and managers who require a working knowledge of cell culture, essential growth requirements and scale-up.
Course Objectives
Learners will be able to:
- Explain what a cell is
- Understand the function of the macromolecules in the cell
- Explain cell division
- Understand the growth requirements for cells
- Explain the difference between adherent and suspension cells
- Name cell culture products
- Understand the use of bioreactors to culture cells for industrial drug manufacturing
Course Content
- Why cell culture?
- What does a cell need to grow?
- The cell as a tool to produce therapeutics