• Danielle DeLucy Recorded
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    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    Developing an Effective CAPA Management and Root Cause Analysis System
    In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner.

  • Danielle DeLucy Recorded
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    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
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    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    Understanding Aseptic Technique and Cleanroom Behavior
    In sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It is providing sterility, safety, and efficacy to the sterile product, especially various injections for patients. Cleaning, Gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.

  • Danielle DeLucy Recorded
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    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    Biosafety and Blood Borne Pathogen Safety in the Lab
    This webinar will provide you with the regulatory framework and recommended guidelines, risk assessment for biological materials, structure of a robust biosafety program and on how to train employees exposed to biological hazards.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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).

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Price: $190.00
    by: Danielle DeLucy
    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.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

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39658 Mission Boulevard, Fremont,
CA 94539, USA.

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