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1 Month. Job Oriented Training Program in QA, QC and RA. Online.

Duration: 1 Month
Mode of Training: Online
Modules: 6 Modules
Certificates: Quality Control, Quality Assurance and Regulatory Affairs
Trainers: : Vinay, Veena and Satish Kumar (Corporate Employees)
Students have learned: 200+
Review:
Fee: 10000 ₹ 20000 Save ₹ 10000/-
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Course Details

Quality Assurance, Quality Control, Regulatory Affairs, CAPA, Market Complaints, Drug Development, Pre-Clinical Trials. (100% Reference within 3-5 Months)

Communication Skills, Interview Preparation, Sample Resume, Mock Interviews, Group Discussions, Guest Lectures, Professional Email Writing, Naurki and Linkedin Profile Setting.

Free Access to Mobile Application

Certification

QA, QC and RA Certification

Industry-Recognized & Central Government (LSSSDC & Skill India) Approved

  • Certificate in Advanced Job Oriented Training in QA, QC and RA by clinOXY, LSSSDC & Skill India

Who this course is for

Fresher’s and Working Employees from B.Pharmacy, M.Pharmacy, Pharm.D, Biotechnology, Microbiology, Chemistry, MBBS, Nursing, Dental, Physiotherapy and Agriculture.

What you'll learn in this course:

Introduction to Quality Management Systems (QMS)

  • Overview of quality assurance (QA) and quality control (QC) concepts
  • Importance of QMS in various industries
  • Historical perspective and evolution of quality management

Quality Standards and Regulatory Requirements

  • ISO 9000 series standards and certification
  • Regulatory requirements in different industries (e.g., FDA regulations for pharmaceuticals, AS9100 for aerospace)
  • Compliance with international standards and guidelines

Quality Planning and Documentation

  • Development of quality policies, objectives, and procedures
  • Quality manual and documentation control
  • Quality planning tools and techniques (e.g., Quality Function Deployment, Failure Mode and Effects Analysis)

Quality Control Tools and Techniques

  • Statistical process control (SPC) methods
  • Control charts and process capability analysis
  • Sampling techniques and acceptance sampling plans

Process Validation and Verification

  • Principles of process validation and verification
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Validation protocols and documentation

Quality Auditing Principles

  • Internal and external auditing processes
  • Audit planning, execution, and reporting
  • Corrective and preventive action (CAPA) management

Supplier Quality Management

  • Supplier selection and qualification
  • Supplier audits and assessments
  • Supplier corrective action and performance monitoring

Risk Management in Quality Assurance

  • Risk assessment methodologies (e.g., FMEA, HACCP)
  • Risk-based decision making in quality management
  • Integration of risk management into QMS processes

Document Control and Change Management

  • Document control procedures and versioning
  • Change control processes and impact assessment
  • Electronic document management systems (EDMS)

Training and Competency Management

  • Training needs assessment and training program development
  • Training needs assessment and training program development
  • Training records management

Continuous Improvement and Lean Principles

  • Kaizen and continuous improvement methodologies
  • Lean principles and waste reduction techniques
  • Six Sigma concepts and DMAIC methodology

Quality Culture and Leadership

  • Building a culture of quality within organizations
  • Leadership's role in promoting quality excellence
  • Employee engagement and empowerment

Introduction to Regulatory Affairs

  • Overview of regulatory affairs and its role in the pharmaceutical, biotechnology, medical device, and other regulated industries
  • Historical development and evolution of regulatory frameworks
  • Regulatory agencies and their roles (e.g., FDA, EMA, MHRA, TGA, PMDA)

Global Regulatory Requirements

  • International harmonization initiatives (e.g., ICH guidelines)
  • Country-specific regulatory requirements
  • Emerging markets and regulatory considerations

Regulatory Submissions and Applications

  • New Drug Application (NDA) and Biologics License Application (BLA) processes
  • Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions
  • Marketing Authorization Application (MAA) procedures

Good Regulatory Practice (GRP)

  • Principles of Good Regulatory Practice (GRxP)
  • Compliance with regulatory standards and guidelines
  • Compliance with regulatory standards and guidelines

Pharmaceutical Development and Manufacturing

  • Chemistry, Manufacturing, and Controls (CMC) requirements
  • Good Manufacturing Practice (GMP) guidelines
  • Good Manufacturing Practice (GMP) guidelines

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Do you still have any questions?

Don't hesitate to leave us your phone number. We will contact you to
discuss any questions you may have

Do you still have any questions?

Don't hesitate to leave us your phone number. We will contact you to
discuss any questions you may have

Register Now