What is GxP Training?
Our program provides in-depth training on GMP, GLP, GCP, GDP, and GVP, covering global regulations like ICH E6 and 21 CFR Parts 210/211, tailored for QA, QC, R&D, supply chain, and clinical teams to ensure regulatory alignment.
GxP Training for Pharmaceutical Compliance
Master Global Good Practices with Tailored Expert Guidance
At Indivirtus Healthcare Services Pvt. Ltd., our GxP training program delivers comprehensive education on Good Manufacturing, Laboratory, Clinical, Distribution, and Pharmacovigilance Practices (GMP, GLP, GCP, GDP, GVP). Tailored for pharmaceutical professionals, we ensure regulatory compliance and operational excellence with practical insights into ICH E6, 21 CFR Parts 210/211, and global standards.
Why is it Critical?
GxP compliance is essential for ensuring product quality, patient safety, and regulatory adherence across manufacturing, clinical trials, and distribution, reducing risks and supporting global market approval.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led GxP training, equipping pharmaceutical teams with the knowledge and tools to achieve audit-ready operations and compliance with global standards.
Our Expert Training Approach
At Indivirtus Healthcare Services, our GxP training is crafted by regulatory experts and auditors with global expertise. We provide customized, interactive sessions covering GMP, GLP, GCP, GDP, and GVP, with a focus on real-world applications like cold chain management, clinical trial compliance, and pharmacovigilance. Our training integrates ICH E6, 21 CFR Parts 210/211, and other global standards to ensure comprehensive learning.
Through case studies, quizzes, and practical workshops, we empower your team to apply actionable strategies, fostering a culture of compliance and quality that aligns with regulatory expectations and enhances operational efficiency.
GxP Training Deliverables
Comprehensive GxP Training Slide Decks: Detailed materials covering GMP, GLP, GCP, GDP, and GVP.
Regulatory Reference Handouts: Guides on ICH, FDA, and EMA standards for ongoing reference.
Quiz-Based Assessments and Feedback: Interactive evaluations to reinforce learning.
Certificate of Participation: Official recognition of training completion.
Practical Implementation Guides: Supplemental resources for real-world GxP application.
Regulatory Compliance & Global Standards
Our GxP training aligns with stringent global standards, ensuring your team is equipped to meet regulatory requirements and maintain audit-ready operations. By adhering to industry-leading guidelines, we deliver training that supports compliance and enhances quality assurance for international markets.
- ICH E6 (R2): Guidelines for Good Clinical Practice in clinical trials.
- 21 CFR Part 210/211: U.S. regulations for pharmaceutical manufacturing and quality control.
- EU GMP Guidelines: European standards for good manufacturing practices.
- WHO Technical Report Series: Global GMP guidelines for quality assurance.
- GVP Modules: Pharmacovigilance guidelines for safety monitoring.
Applications & Use Cases
Our GxP training is essential for pharmaceutical professionals in QA, QC, R&D, supply chain, and clinical teams seeking to ensure compliance across operations. The program supports regulatory audits, cold chain management, clinical trial oversight, and pharmacovigilance. Key use cases include aligning processes with global GxP standards, preparing for facility inspections, and supporting new product development or market expansion.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led GxP training backed by certified regulatory experts with global experience. Our programs ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your team with the knowledge and tools to achieve regulatory success and operational excellence, ensuring compliance and competitiveness in the global market.
Frequently Asked Questions
Frequently Asked Questions
What is covered under GxP training?
GxP training includes GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), GCP (Good Clinical Practices), GDP (Good Distribution Practices), and GVP (Good Pharmacovigilance Practices).
Who should attend GxP training?
Quality assurance, quality control, manufacturing, R&D, clinical, and regulatory teams should attend to stay compliant with global standards.
Does this training cover ICH and FDA regulations?
Yes, the training includes detailed guidance on ICH E6 (GCP) and U.S. FDA’s 21 CFR Parts 210 and 211.
Are there practical case studies included?
Yes, case studies and real-time examples are part of every session to enhance practical understanding.
Can training be customized by role or department?
Absolutely. We offer department-specific and role-tailored training modules for greater impact and engagement.
What does the GxP training program cover?
Our training covers Good Manufacturing (GMP), Laboratory (GLP), Clinical (GCP), Distribution (GDP), and Pharmacovigilance (GVP) Practices, with a focus on ICH E6, 21 CFR Parts 210/211, and global standards, including cold chain and clinical trial compliance.
Who should participate in the GxP training?
The program is ideal for QA, QC, R&D, supply chain, and clinical professionals seeking to ensure compliance with global GxP standards, prepare for audits, or enhance operational efficiency.
How does the training ensure regulatory compliance?
Our training aligns with ICH E6 (R2), 21 CFR Part 210/211, EU GMP Guidelines, WHO TRS, and GVP Modules, ensuring your team meets global regulatory requirements and is audit-ready.
What materials are provided during the training?
Participants receive comprehensive GxP training slide decks, regulatory reference handouts (ICH, FDA, EMA), quiz-based assessments with feedback, a certificate of participation, and practical implementation guides.
Can the training be customized for our team’s needs?
Yes, our training is tailored to your team’s specific roles and processes, such as manufacturing, clinical trials, or supply chain management, ensuring relevant and practical outcomes.
What delivery formats are available for the training?
We offer flexible delivery options, including on-site, virtual, and hybrid formats, designed to accommodate your team’s preferences and ensure seamless learning experiences.