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.
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.
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.
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.
Speakers
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.
