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  • 1 Request Info

    Webinar On Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

    Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/AUDITING-DATA-INTEGRITY-RISKS-509850/JUNE-2017-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar On Cleaning Validations Using Extraction Techniques

    Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CLEANING-VALIDATIONS-EXTRACTION-TECHNIQUES-503258/JUNE-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar On Complaints, Servicing and FDA Reporting

    This presentation provides a framework for understanding, managing, and reporting adverse events to the FDA. It uses plain English to describe the regulatory requirements as well as common quality tools such as flow diagrams and fault tree analysis. This approach helps participants understand and implement the essential parts of the regulations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/COMPLAINTS-SERVICING-FDA-REPORTING-507863/JUNE-2017-ES-TRAININGREGISTRY
  • 4 Request Info

    Webinar On IQ, OQ, PQ in the Verification and Validation Process

    This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/IQ-OQ-PQ-VERIFICATION-VALIDATION-PROCESS-503654/JUNE-2017-ES-TRAININGREGISTRY
  • 5 Request Info

    MRO PLANNING AND SCHEDULING TRAINING

    Click on the name of the course to be taken to our website for class schedule, class outline, and to register. Students are taught how to create a process map to help enable them to identify problems with a particular MRO line. The class then takes an extensive look at forecasting to provide students with an understanding of industry recommended procedures for reliable forecasting. Next, we examine best practices in sales and operations planning and planning and scheduling in an MRO environment. We now discuss best practices in materials resource planning (MRP), capacity management, and production activity control to learn how to make the most of what we have to work with. The class moves on to training in lean manufacturing, just in time (JIT), and the theory of constraints. The class finishes with a discussion of the latest MRO planning software and technologies. Cost of this course is $1,999.00
  • 6 Request Info

    Fixing the Dysfunctional Company

    Click on the name of the course to be taken to our website for class schedule, class outline, and to register. Every company has some degree of dysfunction. This course is designed to reduce dysfunction within manufacturing companies. Since its inception in 2010, the staff of the Academy of Business Training has worked with hundreds of manufacturing and MRO companies to improve their operations. Management of these companies experiences a myriad of problems with production and/or the MRO operation and assumes that’s what needs to be fixed. Therefore, many companies first exposure to us is our Production Planning, Scheduling, and Control course. What our instructors have learned in discussions held during class is most manufacturing and MRO companies are dysfunctional in that the various departments do not work as a team.
  • 7 Request Info

    Statistical Process Control -verification, validation, risk management, Manufacturing, and QA/QC 2017

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective
  • 8 Request Info

    Audit Like the FDA - How to develop and implement an efficient and effective audit program

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.
  • 9 Request Info

    Webinar On Stability Studies and Estimating Shelf Life

    This webinar discusses the steps to set-up a stability study and analyze the results to estimate the product's shelf life. The use of regression models to model the relationship between the response variable(s) and time are presented. Models useful for describing non-linear degradation over time are also presented. Additionally, methods for handling non-normal response data are also discussed. Finally, the use of accelerating variables to shorten the study time and the models required are introduced. The webinar includes several examples to illustrate the methods discussed.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/STABILITY-STUDIES-ESTIMATING-SHELF-LIFE-508052/MAY-2017-ES-TRAININGREGISTRY
  • 10 Request Info

    Webinar On ISO 19011:2011-Guidelines for Auditing Management Systems to Conducting Effective Internal Audits

    This webinar will utilize ISO 19011:2011, ICH Q10 and FDA guidances and explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program, an overview of various cGMP regulations and how to reinforce their quality system, along with potential efficiency enhancements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ISO-19011-2011-INTERNAL-AUDITS-505127/MAY-2017-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar On Working with Compressed Gas: Safe Handling, Use, and Storage

    This webinar will cover the important basic aspects of safe handling and use of compressed gas cylinders. The program will focus on key elements regarding cylinder receiving, transport, storage, and safe handling in the facility and/or laboratory. Federal regulations will be covered, including regulations from DOT, OSHA, and others (NFPA). Cylinder ID requirements, determining hydrostatic test dates and proper shipping on public roads will be addressed.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/WORKING-COMPRESSED-GAS-508282/MAY-2017-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar On Sterilization of Pharmaceutical Products and Medical Devices

    This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide which method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/STERILIZATION-PHARMACEUTICAL-PRODUCTS-MD-502502/MAY-2017-ES-TRAININGREGISTRY
  • 13 Request Info

    ICH Q11- API Manufacturing - 2017

    Overview: This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
  • 14 Request Info

    CAPA System and Uses of CAPA Data - 2017

    Overview: Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.
  • 15 Request Info

    Webinar On Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

    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.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/PHARMACEUTICAL-COMPRESSED-AIR-502789/MAY-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar On Export Control Recordkeeping and Compliance Automation

    As companies move to automate most processes, exporters need to make sure that adequate recordkeeping is factored in. Gone are the days when you could keep hard copies of all your export records in filing cabinets in your office. These days you may be required by your company to reduce or eliminate the amount of paper you keep.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/RECORDKEEPING-COMPLIANCE-AUTOMATION-508029/MAY-2017-ES-TRAININGREGISTRY
  • 17 Request Info

    Writing and implementing effective SOP's 2017- Before 30 April 50% Discount for its All Seminars

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900914SEMINAR?trainingregistry_SEO
  • 18 Request Info

    Design of Experiments (DOE) 2017 - Before 30 April 50% Discount for its All Seminars

    Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality (Critical Process Parameters) and determine the functional relationship that links the process parameters to those Critical Quality Attributes. Screening designs, such as 2k factorial and D-optimal designs are used to determine critical process parameters. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901010SEMINAR?trainingregistry_SEO
  • 19 Request Info

    Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)- Before 30 April 50% Discount for its All Seminars

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: Total Product Life Cycle and Your Medical Device An Overview of U.S. FDA Medical Device Regulation Regulations for Design and Product Development Premarket Notification - 510(k) and Premarket Approval (PMA) Regulations for Production & Process Control Readiness for FDA Facility Inspection Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900772SEMINAR?trainingregistry_SEO
  • 20 Request Info

    Webinar On Human Error Investigations, Root Cause Determination and CAPA Effectiveness

    This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/CAPA-EFFECTIVENESS-507426/MAY-2017-ES-TRAININGREGISTRY