We also recommend: [Executive Session: What Leadership Needs to Know] [Surviving an FDA Inspection] [Creating CGMP and QSR Responsibility and Accountability] [Meetings for Swift and Aggressive Regulatory Enforcement]
Management Session: What Every Manager Needs to Know
address CGMP and QSR issues directly relevant to the executive leadership and
executive teams of manufacturers.
the common 483 observations issued by the FDA.
the basic requirements of CGMP or QSRs
that require the attention of the leadership team.
gaps in compliance.
the issues that needs to be rectified.
About the Class
2. Heard on the Street
3. Observations in review: 483 Trends and consequences
The Park Doctrine
or 21CFR820 Overview
1. Identify the critical elements of compliance
Conduct a risk assessment of critical elements versus company practice
3. Create a path forward
Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.
For a prompt reply to requests and questions: 415.948.5220 | firstname.lastname@example.org | Fax: 954.566.5225
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