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 …
Strategies For Job Seekers: Best Practices For A Strategic …
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Turning Workplace Conflict into Positive Connection
Retention Starts Here: Stop Losing Your Critical Talent and…
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
AI and Human Resources: The Great Opportunity!
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
Cyber Security Incident Response Team Training Program
Excel Power Skills: Master Functions, Formulas, and Macros …
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI
Developing an Agile Workforce with Emotional Intelligence (…
Compliance Under Fire: Navigating I9 Immigration Raids & …
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
Human Error Reduction Techniques for Floor Supervisors
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Secrets Of Psychology - Why People Do The Things They Do
How To Conduct An Internal Harassment And Bullying Investig…
Leadership: Strategic Planning and Decision Making
Marketing to Medicare or Medicaid Beneficiaries - What You …
Polish your Presence on Linkedin - The Powerful Profile
Utilizing A Proven Process When Conducting Sensitive, Inter…
Bootcamp for New Managers and Supervisors: Develop These Es…
Leveraging Artificial Intelligence in HR