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PDA 612 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines

Jun 15 - Jun 16, 2022
Bethesda, MD

  • Education
  • The Americas
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Overview

This 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.

For more options and/or related training courses, please visit the page(s) below.

PDA Environmental Monitoring Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Sheba S. Zaman
Sheba S. Zaman
Novatek
Bio
Sheba S. Zaman
Novatek

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 LIMS, Stability, Contamination Control (Environmental/Utility Monitoring, Cleaning Validation) 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 establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, FDA compliance, Software Implementation and Optimization in a regulated environment.  She also teaches PDA/ISPE/KENX courses for various EM trending topics and is currently serving as the President of Parenteral Drug Association’s (PDA) Southern California Chapter. 

 

Additional Information

  • Learning Objectives

    Learning Objectives

    1. 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.)
    2. Conduct detailed EM data analysis as well as non-routine data analysis for excursions and investigation with an understanding of the regulatory expectations
    3. Explain the inherent risks in EM data management and their counter measures
    4. 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
    5. Demonstrate the ALCOA+ principles including the reason behind each principle and its applicability in routine operations and root cause analysis
  • Who Should Attend

    This training course is intended for professionals who are involved in viable and non-viable environmental monitoring, particularly for those investigating or performing data analysis, including supervision of such analysis.

    Departments
    Quality Control, Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations

    Roles
    Operator/Technician, Supervisor, Manager, Scientist, Auditor/Inspector, Microbiologist

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Travel

PLEASE 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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

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Registration Fees

Early Registration
Registration Type Price By May 1, 2022
Member $1,799
Non-member $2,159
Gov't/Health Auth./Academic* $1,399

Regular Registration
Registration Type Price After May 1, 2022
Member $1,999
Non-member $2,399
Gov't/Health Auth./Academic* $1,399

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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