More than 35% of FDA warning letters cite poor record and document controls. And in the first part of 2012, FDA cited five companies just for poor recordkeeping of regulatory records:
Ningbo Huahui Medical Instruments
Campania Internacional de Comercio
Health One Pharmaceuticals
Edge Biologicals
Gulf Pharmaceuticals
The ugly truth about FDA compliance is that the agency doesn't care what you say you did, FDA investigators only look at the records and documents you've kept. You cannot hope to pass an FDA inspection without the right records.
So what sort of recordkeeping policies do you need? What should be in your SOPs to allow crystal clear record generation and retention? How do you find out what you need to keep? And what do you do when FDA asks for records held by your supplier or stored in email or in archive?
Webinar Includes:
11-step recordkeeping strategy sheet
Checklist of core recordkeeping controls – perfect for adopting into quality and supplier audits
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
Description of the topic
Learn the SOPs and policies to have, how to incorporate risk assessments, how to ensure each of your SOPs generate clear records as proof of compliance, and get the details of an effective FDA recordkeeping program. Learn the types of documents FDA expects you to retain, and where to go to identify the specific documents, correspondence, and records your company is required to keep.
Areas Covered In the Seminar
Types of regulated records required to be kept
How to determine what documents you need to retain and for how long
Example FDA enforcement citations for poor recordkeeping practices
How to develop an FDA records retention schedule
How to handle records maintained at your suppliers
How to deal with email and records kept electronically vs. in hardcopy
SOPs and policies you need to have
Who will benefit
Quality managers and professionals
Regulatory affairs managers and professionals
Document control/records management professionals and managers
Anyone interested in being able to prove compliance to the FDA investigator or a mock FDA auditor
Ningbo Huahui Medical Instruments
Campania Internacional de Comercio
Health One Pharmaceuticals
Edge Biologicals
Gulf Pharmaceuticals
The ugly truth about FDA compliance is that the agency doesn't care what you say you did, FDA investigators only look at the records and documents you've kept. You cannot hope to pass an FDA inspection without the right records.
So what sort of recordkeeping policies do you need? What should be in your SOPs to allow crystal clear record generation and retention? How do you find out what you need to keep? And what do you do when FDA asks for records held by your supplier or stored in email or in archive?
Webinar Includes:
11-step recordkeeping strategy sheet
Checklist of core recordkeeping controls – perfect for adopting into quality and supplier audits
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
Description of the topic
Learn the SOPs and policies to have, how to incorporate risk assessments, how to ensure each of your SOPs generate clear records as proof of compliance, and get the details of an effective FDA recordkeeping program. Learn the types of documents FDA expects you to retain, and where to go to identify the specific documents, correspondence, and records your company is required to keep.
Areas Covered In the Seminar
Types of regulated records required to be kept
How to determine what documents you need to retain and for how long
Example FDA enforcement citations for poor recordkeeping practices
How to develop an FDA records retention schedule
How to handle records maintained at your suppliers
How to deal with email and records kept electronically vs. in hardcopy
SOPs and policies you need to have
Who will benefit
Quality managers and professionals
Regulatory affairs managers and professionals
Document control/records management professionals and managers
Anyone interested in being able to prove compliance to the FDA investigator or a mock FDA auditor
