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 …
Cleanroom, Microbiology and Sterility Assurance Practices f…
Workplace Investigations 101: How to Conduct your Investiga…
Successfully Negotiating the Labor Agreement
Wage And Hour Laws: Ensuring Compliance With The Fair Labor…
Understanding the incredible uses and fallbacks of ChatGPT
5 Key Components of Good Manufacturing Practices to obtain …
How to Manage Conflict in the Workplace
Neutralizing Harassment - How to Promote the Proactive Pers…
Using Better Managerial Decision Making - to get great resu…
Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…
Human Error Reduction Techniques for Floor Supervisors
Changing Behavior: Why Rewards and Punishments Often Aren't…
Using High-Performance Coaching for Managers to Address Per…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Using Stay Interviews To Improve Employee Retention & Engag…
FDA Technology Modernization Action Plan (TMAP) and Impact …
FDA Audit Best Practices - Do's and Don'ts
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
Become an excellent Critical Thinker to greatly improve you…
Learn the Do's and Don'ts of Opening Business Bank Accounts
Project Management for HR, Administrative Professionals, an…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Writing Effective 483 and Warning Letter Responses
Dealing With Difficult People In Life & Work
Managing Toxic & Other Employees Who Have Attitude Issues