Data Integrity for the Laboratory and Beyond - Careful Considerations for Your Next Audit


OVERVIEW
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations.
The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.
WHY SHOULD YOU ATTEND
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices.
These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the regulatory expectations for data integrity compliance.
AREAS COVERED
• Understand the current regulatory position on data integrity
• Discover the criteria for data integrity
• Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
• Learn about approaches to data integrity risk assessment
• Learn about approaches to improve data integrity in a laboratory environment
LEARNING OBJECTIVES
The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices for maintaining data integrity compliance.
WHO WILL BENEFIT
• Site Quality Operations Managers
• Quality Assurance personnel
• Plant Managers and Supervisors
• Manufacturing Superintendents and Managers
• Regulatory Affairs Managers
SPEAKER
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet regulatory compliance.
Use Promo Code TDES20 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
https://bit.ly/2UAFUyB
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

Comments

Post a Comment

Popular posts from this blog

The Effective Manager’s Boot Camp: Managing Your Time Effectively, Difficult People, Communication Skills and All Your Questions Answered In Just 180 Minutes!

Image
OVERVIEW Learn how to manage more effectively than ever before … in just3 hours! You’ll gain insight into more effective time management, how to successfully manage difficult people, how to communicate more effectively so others will respond accordingly … just for starters! We’ll have 3 Q&A sessions, specifically to answer all your questions about how to manage more effectively. Among the topics we’ll address:: Take control of your time...and get control of your entire work day! The speed of everything has changed. Are your time management skills up to the challenge? Do you put off more today than you can ever accomplish tomorrow; exhaust yourself by 4:00 p.m. with only a fraction of your work done; see yourself as a decision maker who never gets around to making decisions; dread the next business meeting—or worse, going back to your desk to see what voice mails and emails await you? If you’re doing more and enjoying it less, it’s time to get out of the time trap an...
Read more

BCBS 239 – Principles of Effective Risk Data Aggregation and Risk Reporting

Image
OVERVIEW Understanding the process required to ensure compliance withBCBS 239 as well as tips on ensuring that the right data is utilized. Finally, a detailed step by step analysis of COSO requirements and what a business can do to meet expectations. COSO continues to provide guidance and establish standards for performance in risk related processes.  BCBS 239 is the latest in a series of instructions which focuses on risk data aggregation. This webinar will include discussions on the risk data aggregation capabilities and internal risk-reporting practices (the Principles) that enhance risk management and decision making processes at financial institutions. BCBS 239 Compliance WHY SHOULD YOU ATTEND Early in 2015, the Basel Committee published the second progress report on bank’s adoption of BCBS 239. Several banks, at that time, stated that they would not be able to comply with the new standards by the 2016 deadline date.  However, regulators are now looking a...
Read more

Effectively Handle Toxic People for Better Productivity and Less Drama in 2020

Image
We all have people who push our buttons and if that relationship is with our boss, colleagues or clients, it can drain our energy, take us off track and infect the other areas of our life. Our upcoming webinar discusses successful strategies and tips for building a positive, productive relationship by knowing how to effectively respond to, cope, and manage the impact of their negative and toxic behavior in the workplace. The webinar covers the following key areas: ·          Identify and control the impact of difficult people so that you can keep the situation from escalating further ·          Differentiate the 4 types of attitudes and understand how they develop in order to keep your cool in a variety of situations ·          Utilize various verbal and non-verbal communication techniques and situational strategies that you can use to de-escalate and effe...
Read more