Upcoming Live Courses
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control0 Available
Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used clean, sanitize, or disinfect surfaces. Understanding the importance of testing and proper use of disinfectants is essential in avoiding regulatory findings. This webinar will review the essentials of disinfectant efficacy testing.
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance0 Available
Change control is a critical piece of any life sciences activity…and a global regulatory requirement. Change control deficiencies are mentioned directly or indirectly in most inspection observation findings. Compliance is a must, and a business imperative. This course will help you get on the right track with your change control programs, documentation, and overall compliance.
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients(2)0 Available
In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” guidance document, which outlined the agency’s thinking on data integrity best practices. In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations. This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop.
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success0 Available
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
Aseptic Process Validation: Top-Tips for Compliance and Success0 Available
If you manufacture sterile therapeutic products, then you know how critical Aseptic Process Validation is to ensuring compliance with mandates and guidance on a global scale. More importantly, you are aware of the impact on patient safety. This interactive session will cover what you need to know, and the best way to go about doing it. Lessons learned “from the trenches” and best practices gleaned from experience will be shared. Additionally, bonus handouts will be offered so you can immediately implement what you have learned.
Developing a Part 11 Compliance Plan in Clinical Research0 Available
This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs0 Available
Pharmaceutical and Biotech Clinical R&D and Pharmacovigilance (PV) Subject Matter Experts (SMEs) are often in the hot seat during internal audits and regulatory inspections. Diligent, proactive companies provide various levels of inspection readiness for many employees, particularly those in middle management. The top inspection readiness priority is to avoid observations by preparing on various levels. This is great! However, audits and inspections do result in observations for many companies. With the increasing number of life sciences companies – and vendors that support them – training on how to develop and write an appropriate Corrective and Preventative Action Plans (CAPAs) is critical. Don’t find yourself beautifully prepared for your audit or inspection, yet unprepared for the aftermath. Join this webinar to learn best practices for preparation.
Competency-Based Training in a GMP Environment – Results Based on Roles and Responsibilities0 Available
This webinar will show you a better way to approach training to target operational task performance while speeding up time to floor, plus reducing errors and retraining at the same time.