GxP, Regulatory Affairs & Documentation for Biopharmaceuticals
From Bench to Approval: Mastering GxP, Compliance & Documentation in Biopharma
About This Course
Biopharmaceutical development operates in a tightly regulated environment where non-compliance can lead to delays, rejections, or product recalls. A strong foundation in GxP principles, regulatory pathways, and high-quality documentation is essential for scientists, QA/RA professionals, and clinical teams working on biologics, biosimilars, vaccines, cell and gene therapies, and advanced therapeutics.
This workshop introduces the practical aspects of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) and connects them to real-world workflows in R&D, manufacturing, quality control, and clinical research. Participants will learn how to create and manage critical documents such as SOPs, batch records, study reports, CMC sections, validation reports, and regulatory submission modules, with emphasis on data integrity (ALCOA+), traceability, and audit/inspection readiness.
Aim
This workshop aims to provide participants with a clear understanding of GxP guidelines (GLP, GCP, GMP), regulatory frameworks, and scientific documentation practices specific to biopharmaceuticals. It will bridge lab/clinical work with regulatory expectations, focusing on compliance, data integrity, audit readiness, and documentation standards required by agencies such as US FDA, EMA, CDSCO, and others. Participants will learn how to prepare, review, and maintain compliant documents across the product life cycle—from preclinical to post-marketing surveillance.
Workshop Objectives
- Understand GxP principles (GLP, GCP, GMP) and their relevance across the biopharma value chain.
- Describe key global regulatory frameworks and pathways for biopharmaceuticals (originators, biosimilars, ATMPs).
- Prepare and review essential GxP documents: SOPs, protocols, batch records, validation reports, and regulatory modules.
- Apply data integrity (ALCOA+) and documentation best practices for audits and inspections.
- Recognize common compliance gaps and observations and how to prevent or address them.
Workshop Structure
Day 1 – GxP Foundations & Biopharma Lifecycle (1.5 hours)
- GLP, GMP, GCP: scope, intent, interlinkages
- Key agencies: US FDA, EMA, CDSCO, WHO, ICH
- Regulatory expectations for biologics, biosimilars, vaccines
- GLP principles and test facility organization
- Raw data, lab notebooks, electronic records, Validation & calibration documentation (instruments, methods)
- Trial documentation: protocol, IB, informed consent, CRFs, TMF
- Safety reporting (SAE, SUSAR) documentation requirements
- Data integrity & subject protection from a documentation perspective
- ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, etc.)
Day 2 – GMP, Quality Systems & Shop-Floor Documentation (1.5 hours)
- Roles of production, QA, QC and RA in GMP environment
- Hierarchy of documents: Quality Manual, Policies, SOPs, WIs, Forms, Records
- Site Master File (SMF), Validation Master Plan (VMP) basics
- Batch Manufacturing Record (BMR) / Batch Packing Record (BPR)
- QC test methods, COA, stability study documentation, Equipment qualification (URS, DQ, IQ, OQ, PQ)
- Process validation & cleaning validation documentation
- Method validation reports for analytical procedures, Deviation / non-conformance reports (NCR)
- Root cause analysis and CAPA documentation, Change control forms and impact assessment notes
Day 3 – Regulatory Submissions, Inspections & Career Orientation (1.5 hours)
- IND/IMPD, BLA/MAA, biosimilar and vaccine pathways (high-level)
- Role of RA in bridging development teams and agencies
- CTD modules (M1–M5) with focus on quality (CMC) module
- Country-specific addenda (e.g., CDSCO requirements – high-level)
- PSUR/PBRER, risk management plans (RMPs)
- Life-cycle management dossiers: variations, supplements, renewals
- Preparing an “inspection-ready” documentation system
- Typical inspection focus areas & document requests
- Responding to observations (FDA 483, Warning Letters) – do’s and don’ts
Who Should Enrol?
- Undergraduate/postgraduate degree in Biotechnology, Microbiology, Biochemistry, Pharmacy, Life Sciences, Biomedical Engineering, or related fields.
- Professionals working in biopharmaceutical R&D, QA/QC, regulatory affairs, clinical research, manufacturing, and pharmacovigilance.
- Individuals interested in GxP compliance, regulatory affairs, and documentation for biologics and advanced therapies.
- Early-career researchers and industry professionals planning to move into quality, regulatory, or compliance roles.
Important Dates
Registration Ends
01/03/2026
IST 7:00 PM
Workshop Dates
01/03/2026 – 01/05/2026
IST 08:00 PM
Workshop Outcomes
- Gain a solid understanding of GxP concepts and regulatory expectations in biopharmaceuticals.
- Learn how to create, review, and maintain regulatory-compliant documentation.
- Understand regulatory pathways and submissions for biologics and biosimilars.
- Be better prepared for audits, inspections, and responding to observations.
- Strengthen their profile for roles in regulatory affairs, QA/QC, and compliance.
Fee Structure
Student Fee
₹1799 | $70
Ph.D. Scholar / Researcher Fee
₹2799 | $80
Academician / Faculty Fee
₹3799 | $95
Industry Professional Fee
₹4799 | $110
What You’ll Gain
- Live & recorded sessions
- e-Certificate upon completion
- Post-workshop query support
- Hands-on learning experience
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