Common Problems and Mistakes in Method Validation in Drug Development Process Seminar
training classes conferences & workshops presented by Online Compliance Panel
register for training on FindaSeminar.com
We are an authorized partner of Online Compliance Panel
Price protection. The price to attend Common Problems and Mistakes in Method Validation in Drug Development Process
is set by the training provider. There is no added
charge for our services.
We honor most training
provider coupons*.
Call a representative to see if your discount coupon
applies.
Privacy. Your personal information
won't be shared with anyone but the training provider Online Compliance Panel.
Security. When you register for this
seminar on FindaSeminar.com your personal data and payment
information is safely collected and processed using secure SSL
encryption technology.
Flexibility. FindaSeminar.com offers
you three ways to register for Common Problems and Mistakes in Method Validation in Drug Development Process
seminar by Online Compliance Panel. Register online, by
phone (800) 349-1935,or fax (800) 712-5569
Who should attend Common Problems and Mistakes in Method Validation in Drug Development Process
Pharmaceuticals, biopharmaceuticals and dietary supplements professionals
Reviews
Write and read Online Compliance Panel reviews
and reviews about the training seminar Common Problems and Mistakes in Method Validation in Drug Development Process on the
Seminar News Network and the
Training News Network.
Frequently asked questions and registration options for the
training seminar Common Problems and Mistakes in Method Validation in Drug Development Process
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. (see
full course description)
Seminar
/ Training class dates & locations
print the agenda
Training Course
Syllabus:
Common Problems and Mistakes in Method Validation in Drug Development Process Webinar
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
Seminar Summary:
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. (see
full course description)
Request
on site training
Email this event...
See similar training..
Other seminars from Online Compliance Panel
