Course offering number:0805-704
Course ID:
2213
Best Practices in SAS Statistical Programming for Regulatory Submission: Understanding and Applying the QC Plan to Validate Summary Tables (FIRST in a Two-Part Series)
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for anyone directly or indirectly responsible for the creation, content or validation of summary tables, data lists and graphs used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21 CFR
Part 11 compliant with effective and practical solutions to address real-world issues will benefit from this unique course.-
SAS Statistical Programmers
- Critical Path Personnel
- SAS Statistical Managers
- Statisticians
- Clinical Data Managers
- Quality Assurance Specialists
- Medical Writers
- Regulatory Affairs Associates
- Director, Statistical Programming
Description
This intense 90-minute accreditied online course focuses on the validation process to assure that correct, consistent and reliable summary tables are reproducible. Discussions will focus on proven techniques to address real-world issues. Get your SAS technical and validation questions answered and learn efficient tips for producing a quality regulatory submission in a timely manner
Module 1: Analysis of potential setbacks
- Identify potential delays and setbacks when creating and validating summary
tables
- Develop plans to address these potential problems
Module 2: Developing a strategy in the QC Plan-
Understand the three levels of checks performed: Self, QC, & External QA
- Develop a game plan for risk management validation
Module 3: Effective methods and SAS macros
to validate summary tables-
Understand the advantages of selected SAS procedures for validating tables
- Apply SAS macros to standardize the validation process
OTHER PARTS IN THIS SERIES:
Part 2: Best Practices in SAS Statistical Programming for Regulatory Submission: Creating Publication-Quality Summary Tables
(Course Offering # 0805-406)
Attend both parts and SAVE $100 OR take either as a stand-alone course. Take both to maximize learning and minimize expense.