PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines
Registration Options
Individual Registration
Group Registration
This live eLearning training course offers a deep dive into the analysis required for Environmental Monitoring (EM) with specific consideration to cGMP and Data Integrity guidelines. As such, the training course is two-fold. The first portion focuses on primarily data analysis for EM. This is for both routine data analysis as well as the analysis required for excursions and investigations with respect to process risks and industry requirements/guidelines. The second portion deals with assessing and maintaining compliance to data integrity guidelines. These two seemingly independent subjects are tied together when we consider that data integrity best practices are required for compliant and meaningful data analysis. Data analysis performed for EM must be risk based, including assessment of data integrity. Furthermore, data integrity tools - such as accurately tracing actions through audit trails - can be crucial to investigations, an area cited by regulators.
Upon completion of this training course, the attendee will be able to:
- Conduct detailed EM data analysis for both routine, state of control monitoring, including frequency, filtering data, grouping data and selection of the meaningful analysis types (e.g. tabular, regression, control chart etc.)
- Conduct detailed EM data analysis as well as non-routine data analysis for excursions and investigation with an understanding of the regulatory expectations
- Explain the inherent risks in EM data management and their counter measures
- Define an overview of the general data integrity guidelines from all organizations and identify possible causes of a breach. Demonstrate true understanding of Quality Culture with respect to its effects on data integrity
- Demonstrate the ALCOA+ principles including the reason behind each principle and its applicability in routine operations and root cause analysis
For more options and/or related training courses, please visit the following page(s):
Contact
Program Inquiries
Training Course Inquiries
Registration Customer Care
Standard Pricing
Standard Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
AcademicMember Only
$599
Non-Member
$599
Featured Presenters
-
Sheba S. Zaman
Head of Product Specialists and Training Services, Novatek International
Read Bio
Sheba S. Zaman
Novatek International
Sheba Zaman has been serving in a technical role at Novatek International for over 20 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems such as Contamination Control, Environmental and Utility Monitoring, Cleaning Validation, LIMS, Stability and Quality Management Systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade managing change and implementation of software solutions, including process mapping, establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, regulatory compliance, software Implementation and optimization in a regulated environment. She also teaches PDA tri/ISPE/KENX courses for various contamination control topics and formerly served as the President of Parenteral Drug Association’s (PDA) Southern California Chapter.
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.