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Courses

  • 41 Request Info

    cGMPs in the Quality Control Laboratory (Medical 2018)

    Overview: 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. By careful review and analysis of the regulations, inspectional guidance, 483 observations and Warning Letter, internal audit observations and deviations, along with a review of laboratory practice and procedures, a laboratory can proactively identify areas for improvement.
  • 42 Request Info

    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.
  • 43 Request Info

    Changing Trend in Risk Allocation - Differing Site Conditions

    Overview This webinar discusses the definition of a differing site condition and why there is a need for a Differing Site Conditions clause in a construction contract. The webinar sets forth the history and purpose of the clause and examines the modern Differing Site Conditions clauses and the changes over time. Why should you Attend This webinar provides a thorough discussion of the Differing Site Conditions clause and how the typical understanding of this 90 year old clause is being eroded by Court and Board decisions. The differing site conditions clause was created by the U.S. Federal government in 1926, in regards to construction contracts. Over the years, the Courts and Boards of Contract Appeals have been slowing changing the interpretation of risk allocation under the clause. A series of Court and Board cases have increased the contractor’s risk concerning differing site conditions.
  • 44 Request Info

    Clinical Data Systems Regulated by FDA

    Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.
  • 45 Request Info

    Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 46 Request Info

    Combination Products 2017

    This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?trainingregistry-September-2017-SEO
  • 47 Request Info

    Complaint and Recall Management Seminar 2018

    This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained.
  • 48 Request Info

    Complaint and Recall Management: A Compliant, Lean Program

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback.
  • 49 Request Info

    Complaint and Recall Management: A Compliant, Lean Program 2017

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901336SEMINAR?trainingregistry-November-2017-SEO
  • 50 Request Info

    Complaints and Recalls | Complaint Handling System in Boston 2018

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901339SEMINAR?trainingregistry-January-2018-SEO
  • 51 Request Info

    Complete 1099, TIN Matching, B-Notice, 1042-S Non-resident Alien and FATCA Compliance Update

    For years the IRS has struggled with the independent contractor, the non-resident alien worker, US citizens with foreign financial accounts and tax collection. They have placed the burden on businesses, non-profits and not-for-profits as well as state and local government to report information about taxable payments they make to their account holders, vendors and customers. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding information reporting on taxpayers by payers - the 1099 and the 1042-S. These time consuming reporting obligations can be streamlined in a number of ways. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901531SEMINAR?trainingregistry-April-2018-SEO
  • 52 Request Info

    Compliance Boot Camp 2017

    This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901152SEMINAR?trainingregistry-November-2017-SEO
  • 53 Request Info

    Compliance for Computer Systems Regulated by FDA

    The seminar 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.
  • 54 Request Info

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.
  • 55 Request Info

    Compliance with the New ICH GCP Revision 2 Addendum - Know the How?

    Overview This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.
  • 56 Request Info

    Compliance with the New ICH GCP Revision 2 Addendum - Know the How?

    Overview This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.
  • 57 Request Info

    Complying with the Revenue Recognition Standard

    This course is designed to provide an overview of the technical guidance and outline the five steps involved in the revenue recognition model, we will also explore some concepts to consider within each step and then evaluate some challenges that specific industries may have when complying with the standard.
  • 58 Request Info

    Conference about Validation Master Planning and Regulatory Expectations

    Overview: Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic. This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation. How best should it be implemented and maintained? What are the types and how many should there be?
  • 59 Request Info

    Control-Analysis Instrumentation used in PAT Continuous [Manufacturing]

    Overview: We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products. Also discuss will be how to build the PAT/CM team and set goals, budgets, and make the change-overs smoothly and efficiently. Requirements for PAT/CM equipment: Speed, Precision, ease of use/installation/calibration/validation Types of Equipment: Near-Infrared, Raman, TeraHertz, (for biopharma) Ultra-fast LC Personnel needed: Engineers, Analytical Chemists, Statisticians, Chemometricians
  • 60 Request Info

    Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

    Overview All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records. Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences. As is often the case, automation and computers do not always replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.