Description
We work in a highly regulated environment. The Good Manufacturing Practices regulations exist to keep our pharmaceuticals safe and healthy. It is never too soon to start training your staff about these critical rules. The regulations, the cGMPs, often feel foreign to individuals working in a product development setting, as if they are designed for “those commercial” folks and not for us.
This course will help streamline your BLA applications down the road and is designed to improve the understanding of the cGMPs, explaining how these critical regulations apply to early stage development companies. This is important today, as the citations and problems with Application Integrity are escalating. It will help create a culture of compliance without impeding your creativity.
We will outline the requirements and provide hands-on tips about how to comply without stifling the very act of development. We focus on change capture rather change control, discuss current best practices and regulations needed for safety. It is recommended that all your personnel receive cGXP training annually.
Session 1: Introduction to the Product Development Cycle and the PHS & FD&C Acts
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: Product Development Cycle: Pre-Clinical; Phase 1; Phase 2; Phase 3 – The purpose and how this alters your testing, manufacturing and concerns. The PHS and FD&C Act, FDA structure and its relationship to product life cycles – Safety, Efficacy and Consistency.
Click HERE to watch an excerpt of Session 1!
cGMPs for Toxicology Studies and Phase 1 Human Studies
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: In-depth look at the critical quality attributes of the Toxicology batches and phase 1 batches, and the cGMPs required to ensure safe and efficacious product for pre-clinical and early clinical trials.
cGMPs for Phase 2 and 3 Human Clinicals
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: Phase 2 is considered the “sweet spot” for making changes to your process and improving your analytical test methods. Therefore, documentation and change capture (and control) are central activities. cGMPs evolve significantly during this time and near commercial levels as you proceed through phase 3 manufacturing. This session covers the requirements and practical how-to tips.
Making the Jump to cGMPs for Commercial Products
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: Moving from Phase 3 cGMPs to Commercial cGMP is a big step. In this session, we will explore the expected risk analysis and how it impacts your cGMP practices. We will also cover the USFDA part 211 cGMPs. This will include some recent inspections, as well as an overview of the regulations.
Application Integrity Issues When Manufacturing Clinical Materials
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: The recent approval of Zolgensma, the second approved gene therapy product in the US, was immediately overshadowed by problems resulting in the FDA looking at application integrity. The result is the entire biopharma industry is now revisiting their SOPs and documentation during clinical development. A focus on lab results.
Recent Pre-Approval Inspection Results
- Instructor: Dr. Laureen Little
- Format: On-demand recording available now.
- Content: FDA audits, risk-assessments for PAI inspections, recent trends and hot topics from recently issued 483 and Post-Approval commitments will be discussed.