Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

Duration: 75 Minutes
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Batch Record Review is a critical part of your operations. This practice is both a vital component to your quality efforts, and a global regulatory requirement. Your firm’s production efforts must be carefully documented. Standard Operating Procedures (SOPs), process controls, and deviations all fall under the purview of batch control. If your efforts are clear, concise, and repeatable, then you have nothing to fear. If your batch control documents are difficult to read, sloppy or worse – non-existent – then look forward to a litany of sanctions, recalls, and costly delays.
Batch Record Review
Instructor: Danielle DeLucy
Product ID: 505980
Upon completion of this session, attendees will learn the fundamentals for reviewing batch records in a pharmaceutical environment. They will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and they will learn how to react to discrepancies found in these records.

Objectives of the Presentation
  • Recognize regulatory requirements for batch records and batch record review
  • Discover the essentials of batch record reviewer qualifications and training
  • Establish a working relationship between production and quality reviewers
  • What to do when a batch fails to meet specifications (discrepancies and deviations)
Why Should you Attend
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential. This webinar with expert speaker Danielle DeLucy, MS, will analyze each of these necessary elements of the batch record review process.

Areas Covered
  • Regulatory requirements for batch record review
  • What to look for while reviewing batch records, i.e., good documentation practices, compliance to critical quality attributes and critical processing parameters
  • Skills and responsibilities of an effective batch record reviewer
  • Tools for effective batch record review
  • Ensuring Production and Quality reviewers coincide with their reviews
  • Extensive Training plan for batch record reviewers and when can they be considered “qualified” to review a record
Who will Benefit
  • Quality Assurance batch record reviewers
  • Production personnel and Production Managers who review batch records
  • Compliance Auditors
  • Manufacturing Management & Scientist
  • Other professionals who review batch records
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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