Available courses
QA RA Course in FOODS
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Overview of cGMP -short Course
Overview of cGMP -short Course
SOFTWARE as MEDICAL DEVICE [SaMD]
1. What is Software as a medical device?
Software is transforming the way technicians detect diseases, how doctors suggest treatments, and how patients manage their health. Far from acting as a support or being tied to a single medical device, software itself is now a discrete product, known as software as a medical device (SaMD).
SaMD provides more effective ways of delivering healthcare at scale. And regulatory premarket submission guidelines give clear guidance on how companies should plan, develop and deploy their SaMD and software in a medical device (SiMD) product.
In 2013, the International Medical Device Regulators Forum (IMDRF) created the Software as a Medical Device working group. Currently chaired by the U.S. FDA, the working group is chartered with developing guidance that encourages innovation while assuring safe and effective products. While SaMD is regulated differently in different countries, this article will focus on the many similarities, and some differences, between the FDA regulations in the U.S. and the MDR regulations in the EU.
TRAIN THE TRAINER [TTT]
Train The Trainer:
Role and responsibilities of a professional trainer Trainer mindset, ethics, and professionalism How adults learn differently Learning styles and training expectations Creating a learner-friendly environment Identifying training needs Defining clear and measurable learning objectives Aligning training with organizational goals Structuring training programs effectively Preparing lesson plans and agendas Time management during training Clear and confident verbal communication Active listening and questioning techniques Handling doubts and encouraging participation Effective use of voice, body language, and eye contact Engaging learners through storytelling and examples Managing classroom and virtual training sessions Classroom training, group discussions, and role plays Case studies and practical demonstrations Blended and online training methods Effective use of PPTs, videos, and visual aids Digital tools for online and hybrid training Creating impactful training materials Managing different learning behaviors Handling difficult questions and participants Maintaining control and positive learning atmosphere Measuring trainee understanding Conducting quizzes, tests, and feedback sessions Evaluating training effectiveness Maintaining training records and attendance Compliance with regulatory and audit requirements Continuous improvement in training documentation Self-evaluation and feedback utilization Updating training skills and knowledge Building confidence and trainer excellence1. Introduction to Train the Trainer
2. Understanding Adult Learning
3. Training Needs & Objective Setting
4. Training Design & Session Planning
5. Communication Skills for Trainers
6. Presentation & Facilitation Skills
7. Training Methods & Learning Techniques
8. Use of Training Aids & Technology
9. Handling Participants & Difficult Situations
10. Assessment & Training Evaluation
11. Documentation & Compliance (Especially for Pharma)
12. Continuous Improvement & Trainer Development
HOW TO FACE SUCCESSFUL AUDIT
Understand the Audit Scope
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Know the standards, regulations, and processes the audit will cover.
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Be clear about expectations and objectives.
Prepare Documentation
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Ensure all SOPs, records, and reports are complete, accurate, and up to date.
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Organize documents for easy access.
Train and Brief the Team
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Make sure employees understand their roles during the audit.
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Conduct mock audits or refresher sessions if needed.
Ensure Compliance
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Review processes to confirm they follow regulations and company policies.
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Identify and correct any gaps before the audit.
Maintain Cleanliness and Order
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Keep the workplace organized, safe, and compliant with standards.
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Proper labeling, storage, and housekeeping matter.
Be Transparent and Honest
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Answer auditor questions truthfully.
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Admit errors if any, and explain corrective actions taken.
Stay Calm and Professional
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Remain courteous, confident, and cooperative.
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Listen carefully, take notes, and clarify doubts politely.
Follow Up After the Audit
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Review audit findings thoroughly.
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Implement corrective and preventive actions promptly
GxP IN PHARMA & MEDICAL DEVICES.
GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. G – stands for “Good” P – stands for “Practice” x – variable depending on the application. GMP (Good Manufacturing Practice), GDP (Good Documentation Practice), GLP (Good Laboratory Practice) and many more.Which sector need to adhere to GxP? i.e.
Medical Device Manufacturers In Vitro Medical Devices (IVD) Pharmaceuticals Life sciences. The GxP requirements outlined by the regulating bodies, define the protocol and controlled processes vital to the safety of their end products. For example, How products are consistently manufactured How new technologies are researched How product designs are tested and challenged How laboratory and manufacturing equipment is calibrated and maintained How their processes are traced from start to finish through controlled documentation How different kinds of products are stored and transported How their workers are trained How records of all these processes are captured and maintained to monitor the ongoing effectiveness of these systems.
This methods will help to: (cont…) Create high performing products of consistent quality in the most efficient way Minimize risk of product failure - proportional to its potential to harm Provide evidence that regulated products are in conformity with regulatory requirements Ensure knowledge is maintained in your organization Establish a mechanism for communication in all levels of your company Achieve accountability across an organization for regulated activity.
GxP defines the best practices that cover every part of the life sciences industry and value chain. All GxP can be seen as subsets of Good Manufacturing Practice (GMP) because they all feed into and support the safe production and delivery of regulated life science products. GxP is about controlling the processes by which these products are developed, manufactured and handled in defined ways throughout the supply chain - ensuring they are of consistent quality and can be used as intended by consumers.
The central pillars Documentation, Communication, Traceability and Accountability To demonstrate that required controls have been observed and ensure potential non-conformance in end products can be identified and corrected Data integrity is key Knowing that data and documentation is accurate, up-to-date and accessible (and that they cannot be changed or tampered with) gives a high level of confidence to companies and regulators Good Documentation Practices (GDP) are central to all GxP s of GxP.
The 5 Ps of Good Practices.
The 5 -S of Good Practices.
AI In Pharmaceutical industry & usefull application
Introduction to; Artificial Intelligence(AI):
Artificial Intelligence (AI) refers to the simulation of human intelligence by machines, enabling systems to learn, reason, and self-correct. AI uses large datasets and algorithms to make predictions, recognize patterns, and support decision-making.
1950: Alan Turing introduced the Turing Test. 1956: Term Artificial Intelligence coined at the Dartmouth Conference. 1950s–1990s: Progress followed by limitations leading to “AI winters”. 1997: IBM Deep Blue defeated chess champion Garry Kasparov. 2000s–Present: AI renaissance due to big data, GPUs, and deep learning, leading to rapid growth in healthcare and pharmaceuticals.HISTORY AND EVOLUTION OF AI:
Why AI used in pharmaceutical industry:
AI used to;
Reduce drug development time and cost Improve accuracy and quality Enable data-driven decisions Integrate biological, chemical, clinical, and operational data Support automation, compliance, and regulatory efficiency
7 QC TOOL
DRA SHORT COURSE FOR ROW COUNTRIES-ONE MONTH
DRA-1M SHORT COURSE
Certificate Course in Regulatory Affairs (API)
- To provide an overview on the general legal requirements to bring a pharmaceutical product to market –whether it is the creation of a new product, or import/export of a product to a new market – and maintaining it afterwards.
- To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
- To create experts in the field of RA documentation and research
- To help students build their career in RA and become RA professionals.
- To provide students with a global knowledge of Regulatory Affairs.
- To create a thorough understanding of important regulatory concepts.
- To create experts in the field of RA documentation and research.
- To encourage continuous learning and development in RA field.
- To clear the basic fundamentals of RA.
- To update knowledge of existing RA professionals.
QA & QC in Cosmetics short course
QA & QC in Cosmetics short course
ARTIFICIAL INTELLIGENCE IN PHARMA AND MEDICAL DEVICES
ARTIFICIAL INTELLIGENCE IN PHARMA AND MDR