Developing a Risk-Based Program

COURSE DESCRIPTION:

Contamination control is critically important in drug manufacturing. Implementation of a robust contamination control strategy is a key regulatory requirement for operating in a cGMP environment. This contamination control event will provide you with a blueprint for developing and implementing a risk-based contamination control strategy. Attendees will learn about best practice cleaning and disinfection strategies and regulatory compliance.

Top 10 Reasons to Attend:

1. Establish the steps to develop a contamination control strategy for your organization
2. Understand the current regulatory landscape and how it impacts your business
3. Identify the impact Annex 1 has on your sterile environment
4. Design the main steps involved in the validation of a disinfection process
5. Understand what a residue is and how to effectively design a program to remove it
6. Engage and interact with industry experts on their cleaning and disinfectant program models
7. Study all the most recent changes to Annex 1
8. Launch a risk assessment for the identification of contamination risks present in your facility
9. Analyze various types of efficacy testing and their potential impact on your program
10. Reduce validation timelines and costs by analyzing a harmonized approach to disinfectant efficacy

Personnel in the Following Environments Should Attend:

• Validation
• QA/QC
• Engineering
• Regulatory Affairs
• Compliance
• Manufacturing

***Attend this event along with Advanced Contamination Control and save $200.00!  Select the dual event ticket type for $1790.00 to register for both seminars and save!***