WEBINARS

 

Laboratory Audits and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

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.

Recording Available

* Per Attendee $299

 

Measurement Uncertainty in Microbiology

webinar-speaker   Michael Brodsky

webinar-time   60 Min

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.

Recording Available

* Per Attendee $249

 

Best Practices for an Effective Cleaning Validation Program

webinar-speaker   Joy McElroy

webinar-time   60 Min

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.

Recording Available

* Per Attendee $299

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

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.

Recording Available

* Per Attendee $299

 

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Recording Available

* Per Attendee $349

 

Validation of GC / GC-MS Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

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.

Recording Available

* Per Attendee $249

 

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

webinar-speaker   Carlos M Aquino

webinar-time   60 Min

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.

Recording Available

* Per Attendee $299

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   90 Min

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.

Recording Available

* Per Attendee $299

 

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

webinar-speaker   Gregory Martin

webinar-time   90 Min

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.

Recording Available

* Per Attendee $299

 

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

webinar-speaker   Andrew Campbell

webinar-time   90 Min

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.

Recording Available

* Per Attendee $429

 

How to undergo an FDA Inspection Successfully

webinar-speaker   Marie Morin

webinar-time   90 Min

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.

Recording Available

* Per Attendee $249

 

Building a Vendor Qualification Program for FDA Regulated Industries

webinar-speaker   Jonathan M Lewis

webinar-time   60 Min

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.

Recording Available

* Per Attendee $249

 

Laboratory Accreditation: Getting there is Just the Beginning

webinar-speaker   Michael Brodsky

webinar-time   60 Min

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.

Recording Available

* Per Attendee $249

 

Sampling Plan for Quality Audits

webinar-speaker   Daniel O Leary

webinar-time   90 Min

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.

Recording Available

* Per Attendee $229

 

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

webinar-speaker   Daniel Norwood

webinar-time   90 Min

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.

Recording Available

* Per Attendee $249

 

Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

webinar-speaker   Michael Brodsky

webinar-time   60 Min

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.

Recording Available

 

The Latest in CLIA Compliance for Clinical Labs

webinar-speaker   Dennis Weissman

webinar-time   90 Min

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.

Recording Available

 

Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns

webinar-speaker   Michael Brodsky

webinar-time   90 Min

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.

Recording Available

 

FDA Inspections: What Regulations Expect

webinar-speaker   Joy McElroy

webinar-time   90 Min

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.

Recording Available

* Per Attendee $249

 

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

webinar-speaker   Henry Urbach

webinar-time   90 Min

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.

Recording Available

* Per Attendee $199

 

 

 

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