Guest Speaker:
Eize de Boer, PhD, Global Manager Life Science Auditing, SGS Group
Compliance is no longer an issue that manufacturers can contain behind closed doors. Watchdog groups necessitate that ongoing compliance become mission-critical:
- GxP and ISO ensure that quality and compliance procedures and processes are sustained and followed
- OSHA to minimize and control the health and safety of employees in high risk or hazardous environments
- Managing implications of information privacy whether on consumer web sites or as defined by HIPAA for patient affairs
The increasing number of global manufacturing networks is introducing new twists in meeting compliance. In 2008, the expectation is that more emphasis will be placed on the supply chain and new guidances may require stricter auditing and supplier controls. Although compliance is born from regulation, it really comes down to how companies manage their quality and understand their current compliance adherence across their organization,
processes, and supply chain.
Do you know your state of compliance? The key to compliance control is good, global auditing programs with sufficient reviews to assess risk, and identify existing or potential quality problems, and critical areas of improvement. Companies that proactively address their compliance management issues, and put audit programs and solutions in place to manage these risks, protect
themselves from fines, oversight, and loss of goodwill.
Join Pilgrim Software and Eize de Boer, Global Manager Life Science Auditing at SGS Group, to learn:
- The importance of implementing a Global Audit Program
- What elements make up a good Audit program - basic mechanics
- Regulatory expectations and differences between FDA and EU requirements
- Preparing your team for an Audit
- Benefits of using 3rd party auditing companies
- How automation can streamline your auditing process