Tuesday March 26, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Within the past several years regulatory agencies have advised their regulated Client firms that the enforcement environment is having the bar raised, i.e., that the regulatory agencies are no longer willing to tolerate the on-going violations that may have previously been tolerated within their Companies. As a consequence, more regulatory actions as well as the threat of seizures and consent decrees are now becoming the norm within these regulated industries. As an example, historically it required three FDA Form 483s to create a Warning Letter. In today’s environment, this will occur after two. Import Alerts (for overseas audits) are also more frequent and usually have a Warning Letter follow within one to four months.
This interactive, Executive Conference Corp. (ECC) webinar is appropriate for those producing small molecules, large molecules and dietary supplements. It will review the strategies that an organization should follow in preparing for an inspection. It will include everything from how the facilities should be maintained in anticipation of an audit to assuring that the Quality Control laboratories do not incriminate the overall facilities. Also, this webinar will include a discussion of employee training and what Annual Training should mean within your organization — and what it does not mean. Areas such as deviations, Out of Specification (OOS), and Corrective Actions/Preventive Actions (CAPAs) will be discussed and include how regulatory agencies initially request these upon their arrival and why. The issue of qualification and validation and the impact of the relatively new FDA Process Validation guidance will also be reviewed.
The objective of this live, interactive ECC webinar is to explore and evaluate what an organization should and can do in preparation for their regulatory inspection and what should be done to assure the most positive outcome. Please gain the most from this webinar by planning to have an interactive, multidiscipline group attend.
Benefits include the following:
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- Do’s and Don’ts within the audit regulatory framework
- The Regulatory Agency – Your Friend or Foe?
- Rationale for a Regulatory investigation
- The Initial Walkthrough – What does it mean; how it creates unknown problems within your organization
- Documents that the Regulatory Agencies initially seek
- Why documents should be presented to the investigators as quickly as possible
- Documents that should be maintained on an on-going basis
- Why your personnel need to understand and follow SOPs
- The laboratory element – the Regulatory Agencies have changed the rules
Why regulated Companies always need to be prepared for a surprise audit - What can be learned from competitors’ FDA 483s, Warning Letters, Establishment Inspection Reports and other official Regulatory actions
- How to use Warning Letters as teaching tools within your organization
- Why your site should have “mock” audits
- Why on-going training is essential to having a successful audit>
Those Who Should Consider Attending Include:
- Quality Assurance
- Quality Control
- Validation
- Metrology
- Manufacturing
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-097