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.
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).
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).
Danielle DeLucy
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 …
Fair Lending in 2025: New Regulations, Examinations and Enf…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Using Emotional Intelligence to Elevate Your Leadership
ChatGPT & HR: How HR Recruiting Professionals Can Leverage …
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
FDA Trends in Compliance and Enforcement in Computer System…
Tattoos, hijabs, piercings, and pink hair: The challenges …
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
How to Write a Successful Job Hazard Analysis
How to Write Right for Better Business Communication
How to Prepare For and Host a FDA Inspection and Respond to…
From Good to Great: The Secrets to an Optimized LinkedIn Pr…
Public Speaking: Overcoming The Fear of Public Speaking
Transforming Anger And Conflict Into Collaborative Problem …
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Workplace Investigations 101: How to Conduct your Investiga…
Navigating Alcohol and Drug Addiction Protections Under the…
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Transforming HR with AI: Unlocking Excellence and Innovation
Creating Employee Handbooks that Protect You and Support th…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Transform Data into Insights: A Beginners Guide to Excel Pi…
50+ new Excel features so far this decade
Mindful Communication:The Key to Meaningful Conversations i…
FDA Proposes Framework to Advance Credibility of AI Models
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Hiring and Retaining Employees in this Crazy Economy
Managing Toxic Employees: Strategies For Leaders To Effecti…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…