Home System concept 7 GMP Training/Lab Course Webinar Bundle – ResearchAndMarkets.com

7 GMP Training/Lab Course Webinar Bundle – ResearchAndMarkets.com

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DUBLIN–(BUSINESS WIRE)–“GMP Laboratory Training – Pack of 7 Courses” has been added to from ResearchAndMarkets.com offer.

GMP Laboratory Training – 7 Course Pack provides the main principles and tools needed to become an expert GMP laboratory professional. It is designed to provide rules, tools and techniques for efficient and compliant management of a GMP laboratory.

This program provides professionals with the training and skills development needed to ensure quality and compliance. GMP laboratory training will be useful to anyone working in or managing a GMP laboratory that supports either the R&D development of a new drug, or the testing and control of a commercial drug brought to market.

This exclusive Pack contains 7 courses:

1. Laboratory Checks – Anticipate inspection based on FDA systems

2. Validation and transfer of analytical methods

3. Audit of laboratory data systems

4. Ensure the integrity and security of laboratory data for FDA/EU compliance

5. Processing OOS test results and conducting in-depth investigations

6. Qualification (IQ, OQ, PQ) and validation of laboratory equipment and systems for regulated industries

7. Establish a product stability testing program

Total duration: 12 hours

Agenda

TOPIC 1: Laboratory Controls – Anticipating FDA Systems Based Inspection

Speaker: Danielle DeLucy

Duration: 75 Minutes

  • Definition of systems-based inspection

  • What are laboratory controls?

  • FDA Inspection Techniques

  • Why the FDA Moved to Systems-Based Inspections

  • Preparing for a lab audit

  • Training of analysts in good inspection behavior

  • Review of materials, equipment, tests and assays

  • Expectations and inspection results / real life quotes

  • Responsibilities of QC/QA Personnel During the Audit

  • Respond to observations or findings

  • real life quotes

TOPIC 2: Validation and transfer of analytical methods

Speaker: Kelly Thomas

Duration: 90 minutes

  • Regulatory Requirements/Advice on Validation of Analytical Methods

  • Defined terminology: qualification, validation, revalidation and verification

  • FDA, EMA, and ICH Requirements and Guidelines

  • Pre-validation of the analytical method – Step 1

  • Analytical Target Profile (ATP)

  • ICH Q8, Q9 and Q10 compliance – Pre-validation requirements

  • Features of Analytical Method Validation – Step 2

  • Specificity, Accuracy, Precision, Linearity, Range

  • LODs and LQs

  • Test method validation protocol

  • Elements of a validation protocol

  • Pre-planning and planning stages

  • Test method validation report

  • Elements of the validation report

  • Elements of the validation protocol and the associated final validation report

TOPIC 3: Auditing Laboratory Data Systems

Speaker: Dr Mark Powell

Duration: 60 minutes

  • Categories of Laboratory Data System (GAMP)

  • Lifecycle management, archiving and backup

  • What counts as raw data?

  • Protect the integrity of analytical data

  • General tips on assigning user privileges

  • Operating system settings.

  • Application settings

  • Commands suitable for chromatographic data systems

  • Practices that facilitate compliance with data integrity requirements

  • Examples of recent FDA warning letters

TOPIC 4: Ensuring Laboratory Data Integrity and Security for FDA/EU Compliance

Speaker: Dr Ludwig Huber

Duration: 75 Minutes

  • Eight Key FDA/EU Requirements for Laboratory Data Integrity and Security.

  • How FDA inspectors verify data integrity and security.

  • Most Common Security and Integrity Issues: Review Recent 483s, EIRs, and Warning Letters?

  • The importance of restricting access to “individual users” rather than groups.

  • Definition, acquisition, maintenance and archiving of FDA compliant raw data.

  • Critical integrity and security issues throughout the life of laboratory data: from data acquisition to evaluation and archiving.

  • Examples of how to ensure and document data integrity.

  • Document laboratory data changes: paper, hybrid systems, electronic.

  • The importance of the electronic audit trail to document data integrity.

  • Electronic audit trail review: who, what, when and how.

  • Ensure timely availability through validated backup and archiving.

  • Going through 10 representative case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

TOPIC 5: Managing OOS Test Results and Conducting In-Depth Investigations

Speaker: Danielle DeLucy

Duration: 180 minutes

Session 1: Guidelines for Detecting an OOS or Atypical Finding

  • Definition Atypical result or out of specification?

  • Review of FDA guidance for industry on reviewing OOS test results

  • Phase I: Initial laboratory investigation

  • Phase II: Large Scale Survey

  • Root cause analysis methods

  • 5 why

  • Organization charts

  • Checklists

  • Fishbone diagrams

Session 2: Testing hypotheses about potential root causes

  • Retest

  • Consider other lots

Session 3: Developing an Appropriate CAPA Plan to Address Any Corrective Actions

  • How to properly document results

  • Example of writing an appropriate OOS survey

THEME 6: Qualification (IQ, OQ, PQ) and validation of laboratory equipment and systems for regulated industries

Speaker: Joy McElroy

Duration: 180 minutes

Session 1

  • Introduction

  • Quality systems, paradigm shift, global perspectives

  • QA/QC Validation

  • Risk assessment

Session 2

  • Measurement, resolution, errors and uncertainty

  • Regulatory and QS requirements

  • The concept of product life cycle

  • USP Chapter 1058

  • Examples of various systems

Session 3

  • Validation strategies

  • Documentation/Validation Master Plan

Session 4

  • Training requirements

  • Examples of various systems

TOPIC 7: Establishing a Product Stability Testing Program

Speaker: Dr David Lim

Duration: 60 minutes

Part 1:

  • Introduction of a stability test plan and program

  • Applicable regulations and requirements

  • General stability considerations applicable to a new product (i.e. potency)

  • Storage conditions

  • Shelf life Duration of studies and expiration dates

  • Container closure requirements

  • Sample size

  • Sampling plan

  • Sample handling and analysis

  • Stability schedule (suggested schedules for performing stability studies)

  • Pre-approval and post-approval studies

  • Stability tests

  • Reformulated products

  • Accelerated temperature studies

  • Test schedule information

  • Suggested time points and expiration dates based on test time points

  • Suggested testing schedule for solid dosage forms

  • Suggested testing schedule for liquid and semi-solid type products

  • Suggested testing schedule for reconstituted products

  • Study temperatures based on product type

  • Ambient temperature studies

  • High temperature

  • Refrigeration

  • freezing temperature

  • Special Moisture Considerations

Part 2:

  • Analytical Testing Considerations

  • Quality Control Release Tests and Methods

  • Criticality of the choice of tests which are indicators of stability

  • Choice of methods with significant data or a stability indicator

  • Method attributes

  • Stability test protocol design

  • How to design a protocol and report

  • Stability test data management and trends

  • Trend data

  • Expiry date extrapolation using data

  • Manual or automated data management

  • Advantages and disadvantages

  • You will also get answers to the following difficult questions:

  • For a medical device that has a storage label of 15-30C; Are stability studies at 15C and 30C or 25C sufficient?

  • For a reconstitution study; the product has an assigned expiration of 24 months; should I do a reconstitution at 12 months (6 hours, 12 hours and 24 hours) and at 24 months (6 hours, 12 hours and 24 hours)?

  • What is the accelerated storage for a product with real-time storage of -20C5C?

  • Is it industry practice to study one year after expiration?

  • If the regression predicts failure before the product expires, what is the next step for stability?

For more information on this training visit https://www.researchandmarkets.com/r/ouofyz