6-Hour Virtual Seminar - Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View Details
4-Hour Virtual Seminar - Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View Details
6-Hour Virtual Seminar - Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View Details
Effective Standard Operating Procedure (SOPs) Development
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation.
Speaker: Danielle DeLucy | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Implementation and Management of GMP Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Implementation and Management of GMP Data Integrity
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Successful Supplier Audits
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is a first step in selecting the correct supplier to meet your outsourcing needs.
Speaker: Danielle DeLucy | View Anytime | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details