Pharma Regulatory & Quality Compliance Course

About Course

Become industry-ready in regulatory affairs, GMP compliance, and quality systems with hands-on training and certification.

The Pharma Regulatory & Quality Compliance Course is a practical, career-focused program designed for professionals and fresh graduates in the pharmaceutical, biotech, and life sciences industries. This course covers critical aspects of GMP (Good Manufacturing Practices), regulatory submissions (CTD/eCTD), quality systems (QMS), and compliance standards required by international regulatory agencies such as the US FDA, EMA, CDSCO, WHO, and others.

Participants will gain in-depth knowledge of regulatory frameworks, learn how to prepare dossiers for global product registration, manage audits, implement CAPA, and maintain data integrity using ALCOA+ principles. The course includes real-world case studies, mock audit exercises, SOP writing practice, and downloadable regulatory templates.

By the end of this course, you will be able to:
✅ Understand global pharma regulations
Learn key regulatory guidelines from US FDA, EMA, CDSCO, WHO, and ICH
Grasp the drug development lifecycle and product registration requirements
✅ Apply GMP, GCP, GLP, and ALCOA+ principles
Implement Good Manufacturing, Laboratory, and Clinical Practices
Maintain data integrity and regulatory documentation standards
✅ Develop and manage quality systems (QMS)
Handle deviations, CAPA, change control, and internal audits
Create and manage essential pharmaceutical documents like BMRs and SOPs
✅ Prepare CTD and eCTD submissions
Understand structure and content of regulatory dossiers
Create mock IND, NDA, ANDA, and DMF documents
✅ Perform validation and qualification activities
Design validation protocols (IQ, OQ, PQ, cleaning, process)
Meet regulatory expectations for quality assurance
✅ Navigate 21 CFR Part 11 & electronic compliance
Ensure compliance for electronic records and signatures
Understand audit trails and system validations
✅ Handle audits and inspections confidently
Prepare for mock audits and real-world inspections
Respond to regulatory observations and implement CAPA
✅ Advance your pharma career
Gain job-ready skills and industry certification
Build a regulatory-ready resume and LinkedIn profile
Understand key tools, SOP writing, and interview preparation

Course Content

Module 1: Introduction to Regulatory Affairs (3 Hours)
Role of regulatory affairs in pharma Overview of drug development lifecycle Key global regulatory bodies: US FDA, EMA (Europe), CDSCO (India), MHRA (UK), WHO, TGA (Australia)

Module 2: GxP Principles and Compliance (5 Hours)
Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Good Clinical Practices (GCP) Data Integrity: ALCOA & ALCOA+ Principles Common regulatory violations and how to avoid them

Module 3: Quality Management Systems (QMS) (5 Hours)
Structure and elements of a QMS in pharma Deviation, CAPA, and change control systems Documentation practices: BMR, MFR, logbooks Internal audits and inspection readiness

Module 4: Regulatory Submissions (7 Hours)
Common Technical Document (CTD) format eCTD and electronic submissions IND, NDA, ANDA, DMF preparation Dossier requirements for US, EU, India, and RoW Real-world case studies of successful submissions

Module 5: Validation and Qualification (5 Hours)
Process validation Equipment qualification: IQ, OQ, PQ Cleaning validation and method validation Risk-based validation approaches Regulatory expectations and documentation

Module 6: 21 CFR Part 11 & Electronic Compliance (3 Hours)
Requirements for electronic records and signatures Technical and procedural controls Real-time data monitoring and audit trails FDA warning letters related to 21 CFR Part 11

Module 7: Mock Audits & Inspection Management (5 Hours)
Preparing for regulatory inspections Conducting mock audits Responding to audit findings (483s, observations) Post-audit CAPA and follow-up

Module 8: Product Registration & Post-Marketing Compliance (4 Hours)
Product life cycle: registration to post-marketing Labeling, advertising, and promotional compliance Pharmacovigilance and safety reporting Product recall procedures and documentation

Module 9: Career & Compliance Tools (3 Hours)
Writing effective SOPs Using regulatory databases and trackers Interview preparation for RA & QA roles Resume & LinkedIn optimization (optional)

Pharma Regulatory & Quality Compliance Course

About Course

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What Will You Learn?

Course Content

Module 1: Introduction to Regulatory Affairs (3 Hours)
Role of regulatory affairs in pharma Overview of drug development lifecycle Key global regulatory bodies: US FDA, EMA (Europe), CDSCO (India), MHRA (UK), WHO, TGA (Australia)

Module 2: GxP Principles and Compliance (5 Hours)
Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Good Clinical Practices (GCP) Data Integrity: ALCOA & ALCOA+ Principles Common regulatory violations and how to avoid them

Module 3: Quality Management Systems (QMS) (5 Hours)
Structure and elements of a QMS in pharma Deviation, CAPA, and change control systems Documentation practices: BMR, MFR, logbooks Internal audits and inspection readiness

Module 4: Regulatory Submissions (7 Hours)
Common Technical Document (CTD) format eCTD and electronic submissions IND, NDA, ANDA, DMF preparation Dossier requirements for US, EU, India, and RoW Real-world case studies of successful submissions

Module 5: Validation and Qualification (5 Hours)
Process validation Equipment qualification: IQ, OQ, PQ Cleaning validation and method validation Risk-based validation approaches Regulatory expectations and documentation

Module 6: 21 CFR Part 11 & Electronic Compliance (3 Hours)
Requirements for electronic records and signatures Technical and procedural controls Real-time data monitoring and audit trails FDA warning letters related to 21 CFR Part 11

Module 7: Mock Audits & Inspection Management (5 Hours)
Preparing for regulatory inspections Conducting mock audits Responding to audit findings (483s, observations) Post-audit CAPA and follow-up

Module 8: Product Registration & Post-Marketing Compliance (4 Hours)
Product life cycle: registration to post-marketing Labeling, advertising, and promotional compliance Pharmacovigilance and safety reporting Product recall procedures and documentation

Module 9: Career & Compliance Tools (3 Hours)
Writing effective SOPs Using regulatory databases and trackers Interview preparation for RA & QA roles Resume & LinkedIn optimization (optional)

Capstone Project
Create a mock CTD submission for a generic drug Draft a deviation report + CAPA plan Submit an SOP and validation protocol

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About Course

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What Will You Learn?

Course Content

Module 1: Introduction to Regulatory Affairs (3 Hours) Role of regulatory affairs in pharma Overview of drug development lifecycle Key global regulatory bodies: US FDA, EMA (Europe), CDSCO (India), MHRA (UK), WHO, TGA (Australia)

Module 2: GxP Principles and Compliance (5 Hours) Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Good Clinical Practices (GCP) Data Integrity: ALCOA & ALCOA+ Principles Common regulatory violations and how to avoid them

Module 3: Quality Management Systems (QMS) (5 Hours) Structure and elements of a QMS in pharma Deviation, CAPA, and change control systems Documentation practices: BMR, MFR, logbooks Internal audits and inspection readiness

Module 4: Regulatory Submissions (7 Hours) Common Technical Document (CTD) format eCTD and electronic submissions IND, NDA, ANDA, DMF preparation Dossier requirements for US, EU, India, and RoW Real-world case studies of successful submissions

Module 5: Validation and Qualification (5 Hours) Process validation Equipment qualification: IQ, OQ, PQ Cleaning validation and method validation Risk-based validation approaches Regulatory expectations and documentation

Module 6: 21 CFR Part 11 & Electronic Compliance (3 Hours) Requirements for electronic records and signatures Technical and procedural controls Real-time data monitoring and audit trails FDA warning letters related to 21 CFR Part 11

Module 7: Mock Audits & Inspection Management (5 Hours) Preparing for regulatory inspections Conducting mock audits Responding to audit findings (483s, observations) Post-audit CAPA and follow-up

Module 8: Product Registration & Post-Marketing Compliance (4 Hours) Product life cycle: registration to post-marketing Labeling, advertising, and promotional compliance Pharmacovigilance and safety reporting Product recall procedures and documentation

Module 9: Career & Compliance Tools (3 Hours) Writing effective SOPs Using regulatory databases and trackers Interview preparation for RA & QA roles Resume & LinkedIn optimization (optional)

Capstone Project Create a mock CTD submission for a generic drug Draft a deviation report + CAPA plan Submit an SOP and validation protocol

Trending Courses

Trending College Workshops

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Module 1: Introduction to Regulatory Affairs (3 Hours)
Role of regulatory affairs in pharma Overview of drug development lifecycle Key global regulatory bodies: US FDA, EMA (Europe), CDSCO (India), MHRA (UK), WHO, TGA (Australia)

Module 2: GxP Principles and Compliance (5 Hours)
Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Good Clinical Practices (GCP) Data Integrity: ALCOA & ALCOA+ Principles Common regulatory violations and how to avoid them

Module 3: Quality Management Systems (QMS) (5 Hours)
Structure and elements of a QMS in pharma Deviation, CAPA, and change control systems Documentation practices: BMR, MFR, logbooks Internal audits and inspection readiness

Module 4: Regulatory Submissions (7 Hours)
Common Technical Document (CTD) format eCTD and electronic submissions IND, NDA, ANDA, DMF preparation Dossier requirements for US, EU, India, and RoW Real-world case studies of successful submissions

Module 5: Validation and Qualification (5 Hours)
Process validation Equipment qualification: IQ, OQ, PQ Cleaning validation and method validation Risk-based validation approaches Regulatory expectations and documentation

Module 6: 21 CFR Part 11 & Electronic Compliance (3 Hours)
Requirements for electronic records and signatures Technical and procedural controls Real-time data monitoring and audit trails FDA warning letters related to 21 CFR Part 11

Module 7: Mock Audits & Inspection Management (5 Hours)
Preparing for regulatory inspections Conducting mock audits Responding to audit findings (483s, observations) Post-audit CAPA and follow-up

Module 8: Product Registration & Post-Marketing Compliance (4 Hours)
Product life cycle: registration to post-marketing Labeling, advertising, and promotional compliance Pharmacovigilance and safety reporting Product recall procedures and documentation

Module 9: Career & Compliance Tools (3 Hours)
Writing effective SOPs Using regulatory databases and trackers Interview preparation for RA & QA roles Resume & LinkedIn optimization (optional)

Capstone Project
Create a mock CTD submission for a generic drug Draft a deviation report + CAPA plan Submit an SOP and validation protocol