Webinar Search Results : 55 Upcoming webinars found.
Eleonora Babayants Tuesday, June 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Corrective and Preventive Action (CAPA) per FDA Requirements
CAPA - Corrective and Preventive Action plan. CAPA is a concept within Good Manufacturing Practice (GMP). It is required for FDA compliance in case of specification situations or other deviations. CAPA is part of the overall quality management system (QMS).

Angela Bazigos Wednesday, June 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

John N. Zorich Wednesday, June 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Louis Angelucci Thursday, June 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Louis Angelucci
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.

Eyal Lerner Friday, June 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485: 2016 and Comparison with 21CFR820 - how to Comply with Both in the same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Laura Brown Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year.

Dr. Ludwig Huber Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Angela Bazigos Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections
This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

Robert J. Russell Wednesday, June 27, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Robert J. Russell
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Robert Michalik Thursday, June 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert Michalik
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project
Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.

Carolyn Troiano Friday, June 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
FDA Compliance and Mobile Applications
This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance.

Angela Bazigos Friday, June 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Lauren Neighbours Monday, July 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lauren Neighbours
Beginning with the End in Mind: Developing a Regulatory Strategy for Product Development
Today's biopharmaceutical companies are charged with making the most out of their limited resources (time, money, and personnel) to successfully bring products to market. Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory program can lead to more efficient product development and greatly increase the likelihood of marketing authorization.

Angela Bazigos Thursday, July 5, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Correctly Submit Pharmacogenomics Data for Faster Approval by the Agency, and What to Expect from the Regulatory Agencies in the Near Future
This presentation, will describe the agency expectations, describe how to correctly submit pharmacogenomics data for faster approval by the agency, and what to expect from the regulatory agencies in the near future.

Danielle DeLucy Monday, July 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
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.

Ginette Collazo Tuesday, July 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Steven S. Kuwahara Tuesday, July 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Steven S. Kuwahara
Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Marina Malikova Tuesday, July 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Marina Malikova
Current Trends in Clinical Research Compliance
Specifically, this webinar will be focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS-Medicare regulations for clinical trials remains a challenge for many clinical sites, sponsors and Contract Research Organizations (CROs).

John N. Zorich Wednesday, July 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Angela Bazigos Wednesday, July 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Deal with the Contradictions and Challenges of Using Cloud in a Regulated Environment
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

Dr. Ludwig Huber Thursday, July 12, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Dr. Ludwig Huber
3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Louis Angelucci Thursday, July 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Louis Angelucci
Similarities and Differences Between an FDA and MHRA Audit
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.

Carolyn Troiano Friday, July 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.

Roger Cowan Friday, July 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Michael Esposito Tuesday, July 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Bad SOPs, Bad Training: Garbage In, Garbage Out
The relationship between SOPs and training is not a common topic but one that affects a large number of employees in the manufacturing sector of pharmaceutical companies. For an SOP to be effective, it has to describe the process with an appropriate level of detail, striking a balance between flexibility and structure. If the writing of the SOP is not written with this objective in mind, it is likely to have a negative impact on training, because text that is ambiguous in the SOP will also be ambiguous in the training. In addition, an SOP is written to capture the essential steps of a process accurately, and its language tends to be "legalese."

Angela Bazigos Tuesday, July 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

John N. Zorich Wednesday, July 18, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: John N. Zorich
3-Hour Virtual Seminar on Statistical Process Control (SPC): A Detailed Introduction
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".

Robert Michalik Thursday, July 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert Michalik
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

Danielle DeLucy Monday, July 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
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.

John C. Fetzer Monday, July 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Teri C. Soli Tuesday, July 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Teri C. Soli
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Robert J. Russell Wednesday, July 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Robert J. Russell
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Dr. Ludwig Huber Thursday, July 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

David Nettleton Friday, July 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Grace Morgan Holmes Tuesday, July 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Grace Morgan Holmes
Protocol Deviation Reporting and Management
Protocols are living documents that are often routinely amended throughout the life of a clinical trial. Due the ever-fluid nature of a protocol's evolution, as well as the potential errors and lack of clarity that they sometimes can possess, it is not surprising many of the issues cited in protocol audits and FDA inspections are noted protocol deviations and violations.

Robert J. Russell Wednesday, August 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Angela Bazigos Monday, August 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Electronic Records & Electronic Signatures, 21 CFR Part 11, Basic Concepts
This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures requirements.

Carolyn Troiano Tuesday, August 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

Jerry Lanese Wednesday, August 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Angela Bazigos Friday, August 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Excel Spreadsheets for 21 CFR 11 Compliance
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

John C. Fetzer Monday, August 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Angela Bazigos Tuesday, August 14, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

David Nettleton Tuesday, August 14, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: David Nettleton
3-hour Virtual Seminar on Data Integrity: Compliance with 21 CFR Part 11 and SaaS/Cloud Software Applications
This webinar details the regulation and how it applies to computerized systems.

Angela Bazigos Thursday, August 16, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Angela Bazigos Thursday, August 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Angela Bazigos Friday, August 24, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections
This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

Laura Brown Monday, August 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.

Angela Bazigos Tuesday, August 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.

Jerry Lanese Wednesday, August 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Ginette Collazo Thursday, August 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Tools for Human Error Reduction
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Edwin Waldbusser Monday, September 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.

Jerry Lanese Friday, September 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
cGMPs in the Quality Control Laboratory
Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

Ginette Collazo Tuesday, September 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Ginette Collazo Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Ginette Collazo Thursday, November 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

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