Batch Record Review and Product Release

Speaker

Instructor: Danielle DeLucy
Product ID: 705921

Location
  • Duration: 60 Min
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. Attendees will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and also they will learn how to react to discrepancies found in these records.
RECORDED TRAINING
Last Recorded Date: Feb-2021

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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.

A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.

This webinar will analyze each of these necessary elements of the batch record review process.

Learning Objectives:

  • 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)

Areas Covered in the Webinar:

  • 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 they can be considered “qualified” to review a record.

Frequently Asked Questions:

  1. Any recommendation or tips on reviewing raw materials, I mean raw materials listed in master batch records?
  2. What if batch records are released from CMO and there are still corrections post disposition. What is the best way to amend any corrections to the batch records?
  3. Would you expect to review the RM release record during executed batch records from CMO? Not all CMO is willing to provide that information because it could be general to all clients?

Who Will Benefit:

  • Quality Assurance batch record reviewers
  • Production personnel and Production Managers who review batch records.
Instructor Profile:
Danielle DeLucy

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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