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GMP/GCP/GLP

Z

Cleanroom Practices

l

Supplier Quality Agreements

i

Bioassays

21 CFR

t

Risk Assessment

r

Sterile Filtration

j

Biocontainment

Sterilization Validation

N

eCTD Submissions

c

Social Media compliance

R

Root Cause Analysis

h

Aseptic Processing

Nano technology

_

EU Drug Approval

k

ICH/USP

Human Error Investigations

Q

Environmental Monitoring

s

Water System Compliance

f

Dietary Supplements

b

Marketing & Labeling OTC Drugs

Z

Supplier Management

\

Rapid Microbiology

Quality Risk Management

Shipping & Distrubition

Cosmetics

Residual Solvents

Audit & Inspections

Good documentation practise

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Some of the most popular Expert Led Content in Pharma

Pharma

Zero Acceptance Sampling Plans to Reduce Inspection Costs

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Pharma

Mathematics of Terminal Sterilization: Probability of Survival -vs- Overkill

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Pharma

Residual Solvents: New Flexibility in Revised USP 467

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Pharma

Environmental Monitoring for Pharmaceutical Clean Rooms

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Pharma

Sterile Filtration – What you need to know to meet Pharmaceutical Validation and Regulatory Requirements

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Pharma

Conducting Effective Investigations of Out of Specification and a typical Laboratory Results

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Pharma

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles //(PL tittle) Developing Optimized Formulations and Lyophilization Cycles Using Differential Scanning Calorimetry and Freeze-Dry Microscopy

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Pharma

Bioanalytcial sample re-analysis, ISR and analytical re-analysis //Sample re-Analysis for Assay/ Sample failure and Incurred Sample Re-Analysisy

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Pharma

Case Studies on Failed Cycles and/or Formulations of Lyophilized Products

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Pharma

Validation Of Pharmaceutical Compressed Gasses

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Pharma

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Productss

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Pharma

Quality Agreements – What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture

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Pharma

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
//(PL Tittle) Lifecycle Approach to Analytical Methods for Drug Products

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Pharma

Lyophilization Process Development and Cycle Design with a Case Study//(PL tittle) An Empirical Process for Optimized Lyophilization Cycle Development

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Pharma

Introduction to Design of Experiments

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Pharma

Writing Validation Master Plans

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Pharma

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

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