What is E-Learn ?
Learning is a life-long journey, for we can always better ourselves through the pursuit of knowledge.
BM e-Learn+ is a training and learning platform that helps industry professionals seamlessly learn anytime, anywhere; remotely or in-person, through customized self-study courses delivered by leading industry professionals and experts.
In doing so, we help you unlock a world of knowledge and possibilities through transformative education solutions. Our ultimate objective is to help leaders and organizations achieve their professional goals through courses tailored to develop critical skills and knowledge that support company goals as well as personal growth and transformation objectives.
Why e-Learn ?
Anticipating complex issues and formulating new strategies remains a challenge, perhaps now more than ever, and industry professionals need to be equipped with cutting-edge insights and the latest know-how if they are to navigate the changing contours of dynamic macroeconomic scenarios.
We help you take the lead through carefully curated pharma training sessions offering expert perspectives that help you stay at the vanguard of your industry.
Each of our expertly designed programs help you realize your professional and developmental objectives in a comprehensive manner.
Each training program features:
6 months access to modules
1 year access to E-courseware
Post-Program Evaluation & Certification
Our events help you achieve your personal and professional growth objectives in a comprehensive manner. Click below to know more about each of our upcoming programs
Global Regulatory Agencies & cGMP compliance, always expect that complaints, failures and deviations are handled in a systematic & timely manner. In this process, the impact on the “Product Quality” has to be assessed, and measures have to be taken to remedy such deficiencies and avoid them in the future.
This workshop will familiarize you with the regulatory requirements and introduce you to the essentials of failure handling. The emphasis is on the independent handling of Complaints, failures and deviations in your everyday work. In the case of studies, practical strategies from practice are presented to you; in breakout sessions, you work out solutions to failures and deviations typically occurring under different scenarios.
Who will Benefit?
- Quality Assurance & Quality Control Department
- Manufacturing Departments
- Product / Process Development
- Qualification / Validation – who are handling failures and deviations & Investigations CAPA.
- R&D Teams
- Regulatory Professionals
What will you learn?
- Systematically handle deviations and failures in the manufacture of API / Pharma products to evaluate them in a cGMP-compliant way.
- Step by Step implementation of CAPA process to ensure effectiveness as per US FDA / ICH guidelines.
- Case studies to demonstrate the evaluation and handling of real-life deviations and failures.
- In breakout sessions, you discuss and work out autonomous solution strategies for losses that occurred.
You can discuss failures and deviations from your daily practice with speakers and colleagues.
- Quality Culture is necessary at all levels for excellence in CAPA handling as the way forward.
- ICH Q9 Quality Risk Management & ICH Q10 Pharmaceutical Quality System requirements.
- Importance of systematic documentation of CAPA process.
This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. Further we are ensuring to make you understand about the new FDA expectations for computer software assurance (CSA).
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course will provide principles and an overview of the overall computer systems compliance.
Who Will Benefit:
This CSV and CSA Training Course will benefit all who use cGXP computerised systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
• Regulatory Affairs
• QA/ QC
• Software Managers
• Project Managers
• Software vendors and suppliers
What will you learn
- This course will provide principles and an overview of the overall computer systems compliance
- This workshop de-mystifies computer system validation approach and sets out the principles which would equip the quality and technology professionals
- The workshop enables a pragmatic and consistent understanding of CSV and Data Integrity requirements
- It will benefit all who use cGXP computerised systems to perform their job functions
QbD is a systematic method of process development which delivers consistency, robustness and increased process knowledge. QbD Approach at the Research and Development Stage itself involves due diligence particularly (but not limited to) with respect to Risk Assessment and Mitigation ensures time and cost saving processes ensuring consistent and high Quality of both APIs and FPPs. The Pharmaceutical Development Process at the Research and Development Level has to ensure identification & implementation of Key elements of QbD by adopting suitable tools. QbD Approach to API & Formulation Development has to be ensured at both Chemical Research/ Product Development and Analytical Research Development and needs to be translated into a viable product at the production scale via successful Technology transfer and Scale- up operations.It is a risk-based strategy to control the desired quality attributes of a drug
This success of adopting the QbD approach is the gateway for achieving and arriving at a time- saving and cost-saving process ensuring a high-quality and stable product consistently.
Who will benefit
- Process scientists & engineers
- Quality Assurance & Quality Control department
- Analytical chemists & Analytical Method Development Laboratories
- Regulatory Professionals
- Contract Research Organization and Contract Manufacturing Organization laboratory and their QA personnel ·
- Auditors (internal and external
- Formulators and manufacturing personnel
What will you learn
- A comprehensive Understanding of the process
- Development and use Quality Target Product profiles
- Eliminates Batch failure by risk assessment and implementation of control strategies
- Minimize deviations and costly investigation
- Increase efficiency of manufacturing process
- Streamline post approval manufacturing changes & regulatory processes
- Empowerment of technical staff
- Opportunities for continual improvement
- An appreciation of QbD in analytical chemistry, formulation, process development and manufacturing
Get in touch to know how we can help create tomorrow’s pharma leaders, today.
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