IChrom
Certified Course for Formulation Development and Analytical Chemical science (Job Oriented Program for Easy Boarding)
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Why choose IChrom
Choose IChrom Labs for top-notch scientific
and talent development services. Our expert
team and state-of-the-art curriculum ensure
your success in the pharmaceutical and
chemical industries worldwide. We foster
responsible chemists and entrepreneurs
through comprehensive education and
personalized mentoring. Specializing in
optimizing methods for various industries, we
offer chemistry courses from high school to
Ph.D. levels. Experience Ph.D. thesis evaluation,
technical writing, free study abroad
counseling, and real-time drug sample
monitoring during our specialized HPLC
training courses. Join us to excel in your
science career!
INTRODUCTION & OVERVIEW
Introducing the Certified Course for Pharmaceutical & Chemical Science by IChrom Research Lab – an all-encompassing program meticulously crafted to empower Science Graduates and individuals with aspirations in the pharmaceutical domain. This exceptional course immerses participants into the core of the industry, with a sharp focus on pivotal subjects including Pharmaceutical Research & Development, Formulation and Process development, Chromatography, cutting-edge lab instrumentation, ICH guidelines, and the crucial realm of Good Manufacturing Practices (GMP).
Unlock a profound comprehension of innovative and compliant (QbD based) development of pharmaceutical chromatographic methodologies, laboratory instruments at the forefront of innovation,
and the regulatory frameworks laid down by the esteemed International Council for Harmonization (ICH). Through an intensive learning journey, students will master the art of upholding Good Manufacturing Practices, ensuring an unwavering commitment to quality, safety, efficacy and alignment with pharmaceutical production standards.
Individually tailored for those with a scientific foundation, this course serves as an ingenious pathway to a gratifying vocation within the pharmaceutical sphere. Upon completion, graduates will emerge as proficient professionals poised to make substantial contributions to the industry’s upward trajectory. Bridging the chasm between theoretical acumen and real-world application, the Certified Course for Pharmaceutical & Chemical Science from IChrom Research Lab is a conduit for nurturing adept and erudite individuals primed to thrive in the dynamic and swiftly evolving pharmaceutical practices.
Important Lessons from the Program:
- Acquire a strategic outlook for molding and magnifying competitive benefits within a rapidly changing setting.
- Elevate aptitude for discerning thought and astute strategic judgment, propelling advancement in your profession.
- Attain understanding into the pharmaceuticals and cGMP compliance.
- Cultivate forward-thinking leadership abilities to adeptly steer through professional ladder/paths.
- Comprehend and harness the potential of current practices employed by leading pharmaceutical enterprises.
Program Highlights
Key Programme Takeaways
- Develop a strategic mindset to shape and amplify competitive advantage in a dynamic environment.
- Enhance critical thinking and strategic decision making skills to propel your career.
- Gain Insights into pharma and food industry.
- Forge proactive leadership competencies to navigate job challenges and opportunities.
- Understand and leverage software’s used by top-pharma companies.
Who should enroll in this program ?
Programme Certificate
Upon accomplishing the program requirements, including a minimum attendance of 75% and achieving satisfactory academic performance, participants will be granted a certificate of completion. It is anticipated that participants maintain an attendance rate of 75% or higher. Attaining an aggregate overall score of 50% and above is necessary. Individuals not meeting these benchmarks will receive a certificate of participation issued by IChrom Research Lab. Certificates will not be conferred for attendance below 40%.
Programme Modules
- AQL- Requirement and expectations
- Heavy Metals- Testing methodology, criticality of test (with example)
- Gas Chromatography-Basics of GC, Principle and operation of GC
- Limit of Detection with case study
- Karl Fischer/Auto-titrator- Basic Principle, operation, criticality, Regulatory guidance and precautions
- FTIR- Basic Principle, operation, criticality, Regulatory guidance and precautions
- Polarimeter- Basic Principle, operation, criticality and precautions
- UV-Visible spectrophotometer- Basic Principle, operation, criticality, Regulatory guidelines and precautions
- Viscometer- Basic Principle, operation, criticality and precautions
- Analytical Balance- Basic Principle, operation, criticality, Regulatory guidance and precautions
- Selection of HPLC/GC columns and Mobile phase in Method development, GC Detector Types/principles and AMV
- Introduction to Pharmaceuticals rules and guidelines
- Conducting the Research
- How to write Patent work
- Formulation development (QbD / Risk based using DOE)
- Process development (QbD / Risk based using design space)
- Technology Transfer (The ten commandments)
- Excipients and its selection
- Film Coating
- Fluid-bed technology
- Modified release Dosage forms
- Liquids (clear, suspensions, semisolids)
- Nanotechnology
- Particle size and its importance
- Bioavailability and bioequivalence
- Differences between Brand and Generic products
- An entire day for QbD workshop (overview of three topics: FMEA. Risk Analysis and Mitigation, PAT)
- Dissolution test- criticality, Regulatory guidance and importance
- Disintegration test- Operations, criticality, Regulatory guidance and importance
- Friability- Operational, criticality, Regulatory guidance and importance
- Degradation Pathways for API and Product, Method development and validation in science section
- Stability Study ICH Guidelines and Stability Chamber Requirements
- Good Laboratory Practices
- ICH Q8 to Q10 Guidelines
- Finished Goods Flow in Quality Control Laboratory
- Investigation Tools- Importance, Applicability and case study
- Packaging Material testing criticality and flow in QC
- MHRA and USFDA Guidelines on OOS
- Validation- Scope and requirement perspectives
- Guideline updation in last 2 years
- 21 CFR part 11 control in Empower software, Data Management and HPLC basics
Deviations, CAPA, Change Controls, Auditing (internal and external), FDA inspections (PAI), Quality Metrics, Meaningful SOP writing, Record Retention, Mock Auditing, Warehouse storage conditions
- Mentoring (a very essential tool for climbing management ladder).
- Talent Development (Job Interview /Resume writing /Tips for Interpersonal skill)
- Mindfulness Sessions
- Leadership
- Individual Description of Instrument
- Chromatography Software Awareness
- System suitability
- Reporting from Software
- PDA/RI detectors
- Method development Tips
- Method validations
- Instrument troubleshooting
- Chromatography for Regulated Market
- Calibration of instrument
- QA/QC SOP guidelines
- UPLC
- Introduction to Pharmaceuticals rules and guidelines
IChrom's Career Services
Modules for Career Management include:
1. Crafting an Impressive Resume & Cover Letter
2. Developing an Outstanding LinkedIn Profile
3. Navigating the Job Search Process
4. Effective Interview Preparation
Notably, former participants of IChrom have successfully secured positions at esteemed companies such as Cipla, Sun Pharma, Haryana Leathers, Alkem, Zydus Cadilla, Alembic, Emami, Baxter, Macleods, Bayer, Johnson & Johnson, Reckitt, and others.
Kindly take note:
This service is exclusively available to residents of India who are enrolled in specific IChrom programs.
IChrom Research Lab does NOT guarantee job placement or career advancement. Career Services are offered to empower proactive career management. These services are facilitated by IChrom’s partners. IChrom Research Lab is NOT directly involved and does not provide any assurances regarding the mentioned Career Services.
The Learning Experience
What is the learning experience like with IChrom Research Lab?
Over 300 students from across India have opted to enhance their skills through IChrom and its esteemed educational partners. Notably, in a recent survey encompassing all our programs, a striking 90 percent of respondents affirmed that their learning goals were either met or surpassed. All course materials will be accessible to students at the beginning of the course. However, to ensure the program effectively delivers the intended learning outcomes, students have the option to engage IChrom for cohesive cohort-based program management throughout the course duration, an inclusion already accounted for in the overall course fee.
A dedicated support team is available five days a week, ready to address inquiries concerning the learning platform, technical concerns, or any other factors that may impact your learning journey.
