PDA 612 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines
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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.
- 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
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.
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Venue Details and Accommodations
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 110Bethesda, MD USA
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814
Please visit the hotel’s website for more information.
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Pricing Options
Standard Registration
Member Price
$1,999GovernmentMember Only
$1,399
Health AuthorityMember Only
$1,399
AcademicMember Only
$1,399
Non-Member
$2,399
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].
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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