April 25: Implementation and Management of GMP Data Integrity Webinar in conjunction with Pathwise @ 11:00AM MST
Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also sever CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.
This webinar will help you:
- Understand the current regulatory position on data integrity
- Discover the criteria for data integrity
- Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
- Learn about approaches to improve data integrity in a laboratory environment.
April 27: HALF-DAY WORKSHOP @ 8:00 AM - 1:30 PM MDT
ISO 13485 Training Overview/Differences Workshop @ 8:00 AM - 12:00 PM MDT
ISO 13485: 2016 Training will include an overview of the revised standard and an in-depth review of the changes. In this training session, you will also have the opportunity to discuss with other quality and regulatory colleagues the business impact and implementation strategies for the changes.
Axeon is a firm that specializes in assisting quality-driven organizations to realize their full vision in achieving their quality and profitability objectives.
Lunch Presentations @ 12:00 PM - 1:30 PM MD
While Australia boasts a strong market for developing medical technology, the landscape is complex and dynamic when it comes to Regulatory Affairs and Reimbursement.
Grant Bennett, Brandwood Biomedical’s CEO, will explore the Australian Regulatory Affairs market; presenting on current trends and emerging issues that may affect organizations operating in the medical device industry. Grant’s presentation will focus on the Therapeutic Goods Administration (TGA)’s Medical Devices Review (MMDR), changes in the European Union (EU) and an overview of risk classification.
Additionally, Sarah Griffin, Brandwood Biomedical’s Principal Reimbursement Consultant, will take a look at Australia's medical device reimbursement system. Australia is a desirable and profitable market for medical devices – with no shortage of applicants. However, there are complexities and challenges for the unwary and the process can be lengthy. Sarah will discuss the latest developments in this market.
Want to only attend the Lunch Presentations? REGISTER NOW