FDA Compliance
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3-Hour Virtual Seminar on Establishing a Robust Data Integrity Program
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on... -
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used... -
3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know
With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative... -
3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vendors in Clinical Research
FDA Regulations and the updated ICH E6R2 addendum note more expansive requirements for vendor oversight including quality systems and risk management awareness. This does not mean after signing the contract, your team finds out they are not compatible with... -
3-Hour Virtual Seminar on GMP Auditing for Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers
Good manufacturing practice (GMP) is an internationally recognized set of regulations to ensure the quality, safety and efficacy of medicines and healthcare products for humans and animals. Compliance is regulated by nationally assigned Competent Authorities, for example: HC (Canada),... -
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This seminar 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... -
3-Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
If your company need to file for 510K approval for Software as a Medical Device (SaMD) or software enabled medical Devices to the FDA for, this webinar is for you. After waiting for seven or more months to find... -
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of... -
3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971... -
3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices
FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for... -
3-Hour Virtual Seminar on Part 11 Data Integrity and Cybersecurity – The Latest Developments
Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized... -
3-Hour Virtual Seminar on Process Validation for Drugs and Biologics
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other... -
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are... -
3-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections
The European Medicines Agency’s (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine...
