Expert-Led Training on Raw Material Qualification, Testing & Supplier Management
Course Description
Ensure your pharmaceutical operations meet the highest regulatory standards with our 2-Day Virtual Seminar on Raw Material Compliance in Pharmaceuticals. This comprehensive course covers critical requirements from Health Canada, USP, and EP standards, focusing on practical strategies to manage raw material sourcing, testing, and documentation.
Every biotech product is an amalgam of multiple raw materials that add purpose and efficiency to it. Since raw materials are the foundation of these products, it is important to have regulatory norms in place for them. Hence, this seminar discusses raw material compliance to ensure every final product meets FDA expectations and guidelines.
We have enforced the idea of good manufacturing practices through several pharmaceutical GMP training programs. However, minute elements like raw materials need critical attention to avoid warning letters.
The world compliance seminars team has come up with a detailed course on raw material compliance to understand the intricacy of an ingredient in a product.
Course Overview
Did you know that over 5,000 companies have received regulatory notices for failing to maintain cGMP-controlled raw materials? Non-compliance with raw material requirements is one of the most common — and costly — issues in pharmaceutical and biotech manufacturing.
This 2-Day Live Online Course goes beyond standard cGMP training to focus specifically on the regulatory requirements, testing, and qualification of raw materials as outlined by Health Canada, USP, and EP.
Participants will gain a deep understanding of how to establish, implement, and maintain a compliant raw material control program that meets FDA, EU, and Health Canada expectations.
Key Learning Outcomes
By attending this comprehensive workshop, you will learn how to:
- Develop representative sampling plans for accurate raw material testing and inspection.
- Implement best practices for releasing components, containers, closures, and packaged products.
- Apply proper sampling and contamination control techniques to maintain sterility and product integrity.
- Define acceptance and rejection criteria for materials based on regulatory standards.
- Understand the impact of raw material variability on product quality and patient safety.
- Align your raw material management system with current cGMP and international compliance guidelines.
- Apply Health Canada, USP, and EP standards in raw material qualification and supplier approval.
Course Agenda – 2-Day Virtual Seminar
🔹 DAY 01 – Regulatory Frameworks & Raw Material Impact
- Compare and contrast FDA, Health Canada, ICH, USP, and EP regulatory requirements
- Explore various raw materials and their impact on product quality and patient safety
- Understand the role of raw materials in the timely production of pharmaceutical products
- Deep dive into the impact of the most commonly used raw material in large molecule production and its user implications
- Review regulatory requirements from Phase 1 to Commercial Manufacturing
- Discuss the role and limitations of Certificates of Analysis (CoA) vs. additional testing requirements
🔹 DAY 02 – Testing Strategies & Risk Management
- Evaluate the use of compendial vs. non-compendial testing – benefits and limitations
- Understand regulatory risk management (ICH Q9) related to raw materials
- Learn best practices for sampling strategies and testing methods
- Explore the impact of ASQ (American Society for Quality) principles and the √(N+1) approach in determining sample size and attribute testing
- Apply concepts through practical case studies
- Analyze real-world Warning Letter examples to highlight compliance challenges
Who will benefit from the course?
Raw material compliance is currently the talk of the town and upskilling yourself will help you in building a positive career. Moreover, additional knowledge of cGMP violations will help you excel in the department.
Below are some professionals who will benefit from this FDA compliance training:
· Regulatory and Compliance Professionals: Develop the ability to identify loopholes and build a better system for raw material procurement and processing.
· Manufacturing and Quality Engineers: Assess the quality of the product internally and set a benchmark for the entire team to avoid warning letters and product recalls.
· Document Control Specialists: Gain perspective on documenting the characteristics of the raw material appropriately for future reference.
· Quality Auditors: In-house auditors play an essential role in product examination and are responsible for giving critical feedback on the entire system.
· Project Managers: The course will help them understand basic regulations related to raw materials so they can take suitable action and manage product development.
People Also Ask
Q1 Is there any fixed number of raw materials as per raw material compliance?
No. There is no cap on the number of raw materials a manufacturing unit can source or procure. Sometimes a small molecule might require up to 20 components while a larger biomolecule may need more than 60 components. At the end of the day, the inspection team only looks after the regulatory norms followed by the individuals.
Q2 Does the course focus on minimizing pathogenic agent contamination in incoming raw materials?
Yes. Raw material compliance emphasizes avoiding contamination at every stage. Since the purity of the raw material impacts the quality of the final product, control strategies are discussed in this seminar.
Q3 What are the different components before the release of raw materials as per raw material compliance in the cGMP environment?
Before the release of raw materials, they need to be stored in controlled conditions. Furthermore, they are segregated and labeled as per the norms. The final step is to test these materials and qualify them for further use.
Benefits
Upon completion of this course, participants will have a thorough understanding of raw material requirements as specified by Health Canada, USP, and EP. They will possess practical skills to effectively manage raw materials throughout their lifecycle, ensure compliance with regulatory standards, and contribute to the overall quality and safety of pharmaceutical products.
This live training Seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- Q/A Session
- Free Handouts on Raw Material Requirements (Health Canada/USP/EP)
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Seminar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminar live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Hear from Our Learners: Real Success Stories
⭐️⭐️⭐️⭐️⭐️
“This course clarified the complex requirements for raw materials under Health Canada, USP, and EP standards. The practical tips and case studies helped our QA team improve compliance immediately.”
— Quality Assurance Manager, Pharmaceutical Company
⭐️⭐️⭐️⭐️⭐️
“I now fully understand supplier qualification, Certificates of Analysis, and documentation expectations. The course provided actionable solutions to common raw material challenges in cGMP environments.”
— Regulatory Affairs Specialist
Know Your Faculty
Dr. Barry A. Friedman, Ph.D. – Biopharmaceutical & GMP Compliance Expert
Dr. Barry A. Friedman is a leading biotechnology and pharmaceutical consultant specializing in GMP compliance, aseptic processing, sterility assurance, and microbiology training. With over 30 years of industry experience in biopharmaceutical manufacturing and regulatory compliance, he has held senior roles including Director of Quality Control at Cambrex Bio Sciences and Laboratory Director at Chesapeake Biological Laboratories.
Dr. Friedman holds a Ph.D. in Microbiology from The Ohio State University and an M.S. in Microbial Genetics from Michigan State University. He is a trusted industry speaker, GMP trainer, and consultant helping pharmaceutical and biotech companies meet global quality and regulatory standards.
