Common Problems and Mistakes in Method Validation in Drug Development Process

Duration: 60 Minutes
Validation of test methods is a critical requirement for the drug development process. Testing of drug substance and drug product for quality requires validated methods. In addition, testing samples for PK/PD studies requires methods that are consistent, robust, rugged, sensitive, and specific in a variety of matrices. Collecting sufficient data prior to validation that can reliably support acceptance require is a frequent issue. Setting appropriate acceptance criteria based on data from final development and qualification is important for assay performance in the validation. This webinar will address issues that arise during development and validation that lead to failure and rework. The webinar also includes approaches to validation that can prevent failure and increase successful completion of validation.
Method Validation in Drug Development Process
Product ID: 509856
Objectives of the Presentation
  • Why method development is critical for a good method validation
  • Importance of understanding trends and outliers
  • Appropriate handling and setting of specifications for reagents and samples
  • Importance of pre-validation (qualification) data
  • Implementing good training procedures
  • Defining the validation process
  • Learning from failures
Why Should you Attend
Validation rework is costly and impacts timelines negatively. Properly preparing for validation contributes to successful, on time completion of method validations. This webinar provides information that will assist attendees with identifying and correcting common issues that may arise during validation of methods required in drug development. Issues revolving around lack of supporting data for validation acceptance criteria, lack of analyst training, and not testing specific parameters during development will be addressed. Attendees should gain knowledge to help resolve potential issues that may arise during validation.

Areas Covered
  • Defining the method selected for development
  • Certifying the reference standard
  • Setting appropriate limits for reagents
  • Reagent supply and sample handling
  • Testing robustness/ruggedness/selectivity/specificity prior to validation
  • Analyst training
  • Peer review of the test method
  • Validation protocol and templates
  • Preplanning
  • Documentation of deviations and failures
Who will Benefit
Pharmaceuticals, biopharmaceuticals and dietary supplements professionals including:
  • Method development scientists
  • Method validation scientists
  • Quality control professionals
  • Quality assurance professionals
  • Manufacturing professionals
  • Laboratory managers
  • Auditors
  • Research and development
  • Regulatory Affairs professionals
Topic Background
Test methods must be validated prior to use during critical phases of drug development. Validation failures are a common problem that increases cost of drug development and delays product timelines. Some of the common problems that negatively impact the quality of validations may be avoided with proper planning and assessment of development data. This webinar provides insight into scenarios that may become problems during method validation and addresses procedures designed to overcome the challenges.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
View More