1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
About this course
Companies are required by law to audit their own operations and the operations of their vendors, suppliers and contract laboratories. In addition, Regulatory Authorities are conducting inspections of companies prior to licensing a product and periodically later when product is manufactured for the market.
This course teaches how to effectively audit for GMP compliance and how to behave if being audited. The course therefore is equally useful for both, auditors and auditees.
The course further instructs how to properly document the inspection and how to appropriately follow up on commitments made during and after the audit.
To get the most out of this course participants should have at least a basic knowledge of GMP requirements and expectations of regulatory authorities.
YOU WILL BENEFIT FROM THIS COURSE…
if you have part in conducting or receiving audits
if you belong to Quality Assurance or Quality Control
if you are responsible for regulatory compliance or are auditing for GMP compliance
if you belong to manufacturing
if you are responsible for facility management, engineering or maintenance
if you are a supplier to the healthcare product manufacturing industry
if you are a validation contractor
if you simply need a better appreciation and understanding of how to conduct compliance audits or how to behave when being audited
THIS COURSE WILL IMPROVE YOUR KNOWLEDGE OF...
how to audit vendors, raw material manufacturers, contract manufacturers and contract laboratories
how to effectively conduct internal and external audits
how to perform regulatory mock preapproval inspections
how to behave during audits
how to resolve disagreements and how to achieve cooperation during an inspection
techniques to quickly find potential violations
how to address objectionable observations
how to appropriately respond to concerns of auditors and regulatory inspectors
how to appropriately respond to Form-483 observations and how to avoid the issuance of warning letters
Copyright Center for Continuous Education