Your Shopping Cart
“This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs.”
Analytical methods should be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated.
Recent guidance on method validation and transfer has been produced by FDA and EMA, and USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures.
This 2-day workshop will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols. The course includes workshops to help attendees plan method validation and to select appropriate acceptance criteria, as well as checklists for validation protocol and analytical method contents.
Learning Objectives:
- Understand the regulatory requirements for validation of analytical methods
- Learn how to plan, execute and document development and validation of in-house methods
- Be able to explain the different requirements for validation, verification and transfer of analytical procedures
- Understand the principles of validation of in-house methods, verification of compendial methods and method transfer
- Know how to demonstrate equivalence to compendial methods
- Understand the important qualities of stability-indicating methods
- Be able to select test parameters, test conditions and acceptance criteria for different analytical measurements
- Know how to plan, justify and document revalidation after method changes
- Understand important indicators of the suitability of a method for routine QC use
- Understand approaches for the statistical evaluation of validation test results
- Understanding what questions will be asked during audits and inspections and how to answer them
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
Who will Benefit:
- Quality assurance personnel
- Quality control and method development analysts
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs personnel
- Consultants
Day 01(8:30 AM - 4:30 PM)
- 8:30-8:59 Registration Meet & Greet.
- 9:00 AM Session Start
- Day 1 – Lectures and Workshop Exercises
- Lecture 1: Regulatory Background and Requirements
- FDA, EMA and international requirements (ICH Q2)
- Method validation terminology
- Compendial guidance on method validation, verification and transfer:
- USP General Chapters 1033, 1092, 1210, 1224, 1225, 1226 and 1467
- Ph. Eur. 5.21 – Chemometric Methods applied to Analytical Data
- EU GMPs: Chapter 6 and Annex 15
- Recent FDA and WHO method validation guidelines
- Different requirements for GLP, GCP and GMP
- Recent FDA and EMA enforcement action regarding method validation
- Introduction to quality risk management (ICH Q9)
- Exercise: evaluating risk in method validation, verification and transfer
- Lecture 2: Preparing for Method Validation
- Analytical Instrument qualification (USP <1058>)
- Computerized data systems (21 CFR 11, EU GMPs Annex 11 and GAMP 5)
- Validation of chromatographic data systems
- Validation and control of Excel spreadsheets
- Qualification of reference standards and materials
- Evaluating method performance prior to validation
- Lecture 3: Validation of Analytical Methods
- Developing a validation plan and SOP
- Phase-appropriate method validation
- Experimental approaches to method validation: accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range and robustness
- Demonstrating specificity: stress studies and impurity standards
- Dealing with validation failures
- Exercise: example validation report
- Lecture 4: Verification of Compendial Methods
- Scope, objectives and requirements of USP <1226>
- Changes allowed to chromatographic methods: USP <621> and Ph. Eur. 2.2.46
- Risk-based approach to method verification - which validation parameters should be verified?
- Method verification acceptance criteria
- Exercise: planning a method verification exercise
Day 02(8:30 AM - 4:30 PM)
- Day 2 – Lectures and Workshop Exercises
- Lecture 5: Transfer of Analytical Methods and Procedures
- Method transfer objectives
- Method transfer approaches
- Risks in method transfer
- Writing an effective transfer protocol
- Preparing the receiving laboratory for method transfer
- Method transfer to new technology: HPLC to UHPLC
- The method transfer report
- Exercise: planning a method transfer exercise using comparative testing
- Lecture 6: Demonstrating Equivalence to Compendial Methods
- Method validation vs. equivalence testing
- Definition, objective and scope of alternative methods
- Justification for the use of alternative methods
- FDA and USP requirements
- Equivalence testing - what and how much?
- Documentation requirements
- Lecture 7: Maintaining the Validated State (Lifecycle Management)
- Monitoring method performance: system suitability testing and quality control samples
- Change control for analytical methods
- Handling method changes pre- and post-approval
- Revalidation of analytical methods: when, and what to test
- Method review
- Continuous improvement
- Lecture 8: Recent Developments
- Lifecycle approach to analytical methods
- Method development and validation using Quality by Design principles
- Validation of bioanalytical methods according to the FDA and EMA guidelines
- Measurement uncertainty

Mark Powell
Director, Mark Powell Scientific Limited
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
Location:
San Francisco, CA
(Venue to be announced shortly)
March 23-24, 2020

Lab Compliance Seminar by Speaker: Understand guidelines from FDA/EMA, USP and ICH
Testimonials
See What People Say About Us
Speaker is very knowledgeable and the supporting material provided by him is very helpful.
SQA Compliance Auditor,
AbbVie Inc.
There is sufficient information in the seminar and the presenter is very professional.
Head of Quality,
Bayer HealthCare.
Definition of raw data and its relationship of e-signature application topic was most valuable to me as we were evaluating the gap in our company and this handy data before doing that will help us to get the requirement.
Assistant Manager,
QA, SHL Group Limited
Information and resources provided by Speaker is very informative. Additional resources provided by him has practical and applicable approach. What I have learned will be helpful in reinforcing compliance in the company with QA.
Assistant Manager,
Quality Assurance, EirGenix, Inc
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656
Media Partner:Local Attractions of San Francisco, CA

Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity
We need below information to serve you better
You Recently Viewed