cGMP auditing is a quality system requirement for both the qualification of critical suppliers and for internal audits to help evaluate and assure regulatory compliance. In addition, the same areas used for both of the above listed categories can also apply to hosting regulatory or third party audits that are common place. An effective auditing program is a combination of knowing the regulations, what are the areas of focus based on risk assessments and adequate training in how to gather information and make accurate evaluations.
Regulatory requirements will be highlighted that apply to auditing, along with suggestions on how best to perform the audits, address the deficiencies found and expectations for corrective actions that may need to be implemented. Additionally, the webinar will provide recommended approaches to addressing regulatory audit findings.
In both cases there are areas of focus that need to be reviewed and trained on in order to assure topics that represent risk to the quality of the product or device are adequately covered.
Why Should You Attend:
The term “audit” conveys feelings of anxiety due to not knowing what to expect, fear of potential findings, frustration with the time it takes from our schedule and frustration with additional paperwork to address any observations.
Areas Covered in this Webinar:
This webinar will hopefully help to reduce these feeling by having a better understanding of audits and how to prepare for them. In addition, regulatory suggestions for how best to address findings will also benefit companies when given any 483s. In addition, actual case examples will help highlight the points discussed.
• Regulatory expectations that deal with auditing, vendor qualifications and internal auditing
• Checklist of items to cover during audits of vendors and internal audits
• Training for performing and handling audits...what to look for, what to do and not do
• How best to evaluate audit findings
• Recommendations for how best to address FDA audit findings (483 observations)
Who Will Benefit:
• Regulatory Personnel
• Quality Assurance and Quality Control Personnel
• Manufacturing Professionals
• Vendors/ Suppliers
• Engineering Staff
• Purchasing Staff
• Packaging and Labeling Staff
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries.
Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
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