Dr. Afsaneh Motamed Khorasani
Product Id: 705131
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Dr. Afsaneh Motamed Khorasani
Product Id: 705130
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Carlos M Aquino
Product Id: 704617
The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
Product Id: 703902
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
Product Id: 704329
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Product Id: 704086
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Product Id: 705259
This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.
John E Lincoln
Product Id: 702766
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
Product Id: 702534
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
Product Id: 703538
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. Learn how to identify and avoid potential pitfalls during deviation investigations.
Product Id: 705170
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
Jonathan M Lewis
Product Id: 703467
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
Product Id: 703285
This training on laboratory accreditation will focus on ISO/IEC 17025 requirements. Attendees will learn how to develop and maintain a quality management system to ensure compliance with the international laboratory accreditation standard.
Daniel O Leary
Product Id: 702581
This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.
Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists
Product Id: 705169
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.
Product Id: 705299
This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.
Product Id: 705374
This webinar will cover in detail the regulatory requirements of Clinical Laboratory Improvement Amendments (CLIA). It will also discuss major lab quality standards such as facility administration, general laboratory systems, personnel qualifications & responsibilities, proficiency testing and more.
Product Id: 705298
This training program will cover the requirements of ISO/IEC 17025 laboratory accreditation standard. It will focus on management components of QMS including document control, quality system, service to customer, internal audits and much more.
Product Id: 705346
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Product Id: 703058
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.