21 CFR PART 11 COMPLIANCE FOR ELECTRONIC RECORDS AND SIGNATURES

🎤  Edwin Waldbusser      |  📅  April 25, 2023   |  🕒  11:00 AM Eastern Time US

Description: Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means. The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained.

Description

Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical Device cGMP’s. It can be a key tool in meeting the Production and Process Control (P&PC) requirements of those same CGMPs and those of the Drug CGMPs, 21 CFR 211. SPC used in P&PC and the required periodic quality system analysis, helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste (rework or scrap). SPC provides advantages in any production process where the “conforming product” (product meeting specifications) output can be measured.

Why You Should Attend:

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.

FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.

You will also receive a 21 CFR checklist and a Test protocol form as handouts.  

Areas Covered in the Session :

• Origin of the regulation and changes in Interpretation
• Electronic Records
• Electronic Signatures
• Data Security
• Open, closed and hybrid Systems
• Validation Methods
• Risk Analysis

Who Should Attend :

• Quality Assurance Departments
• Regulatory Affairs Departments
• Engineering Departments
• IT Departments
• Validation Departments
• Documentation Departments