Introduction  (0.5 hour)

·        Q7A

·        Course Objectives

·        Course Methodology

·        Structure of FDA and recent changes

·        Introduction to types of cGMP guidance documents

·        Compliance Philosophy

Facilities and Equipment Design for Contamination Control  (1.5 hours)

·        General

·        Media Preparation

·        Fermentation

·        Purification

·        Pre- and Post-Viral Segregation

·        API

·        Equipment Design

Environmental Monitoring and Exceeded Limit Investigations  (1 hour)

·        Why API GMPs

·        Area Classifications

·        Air Requirements

·        Tests

·        Selecting Sites

·        Limits

·        Frequency

·        Trending

EXERCISE: Facility Design/EM  (0.5 hour)

Understanding Equipment Cleaning, Sanitization, and Sterilization (1 hour)

·        Understanding Cleaning

·        Understanding Sanitization and Sterilization

Cleaning Validation/Verification  (1.5 hours)

·        General

·        Cleaning Procedures

·        Sampling Techniques

·        Test Methods

·        Acceptance Limits

CASE STUDY:  Cleaning Validation  (0.5 hour)

Critical Materials and Supplier Qualification Programs  (1 hour)

·        Defined

·        Materials Control

·        Contamination Control

·        Critical Materials

·        Example Strategies

·        Supplier Qualification

·        Raw Materials for a Biopharmaceutical Process

·        Materials Compliance Program

EXERCISE:  Materials  (0.5 hour)

DNA Technology  (1 hour)

·        Example: Transfer and Cloning of a Gene

·        Protein Synthesis

Cell Bank Generation, Characterization and Maintenance  (1 hour)

·        Introduction

·        Why High Level of Compliance

·        Facility and Equipment

·        Raw Materials

·        Manufacturing

·        Testing

·        Storage and Access

Laboratory Techniques  (1.5 hours)

·        SDS-PAGE

·        DNA Sequencing

·        ELISA

·        HPLC

·        Immunoblot

·        Southern Blot

·        DNA Content

·        Cell Based Assays

·        LAL

Laboratory Systems  (1.5 hours)

·        Facilities and Equipment

·        Sample Handling

·        OOS Investigations

·        Standards and Media Controls

·        Method Validation

·        API Stability

EXERCISE:  Laboratory Investigation  (0.5 hour)

Fermentation and Cell Culture Technology and Processing  (1 hour)

·        Typical Stages of Product Production

·        Fermentation Technology

·        Cell Culture Technology

·        Fermentation and Cell Culture Operations

·        Vessel Preparation (pre-sterilization)

·        Vessel Sterilization

·        Vessel Preparation (post-sterilization)

·        Inoculation

·        Feeds and Monitoring

·        Transfers

·        Control Systems and Typical Outputs

·        Vessel Sampling

·        Vessel Shutdown and Cleaning

Harvesting and Recovery Techniques  (1 hour)

·        Microfiltration

·        Capture Chromatography

·        Centrifugation

·        Homogenization

·        Harvesting Operations

·        Auditing Considerations

Purification Techniques and Processing  (1 hour)

·        What

·        Development Run Example

·        Transfer Run Example

·        Techniques for Chromatography

·        Techniques for Ultrafiltration

·        Diafiltration

·        Centrifugation

·        Final Filtration

·        Bulk Lyophilization

Investigations, Reprocessing/Reworking, Packaging/Labeling  (1 hour)

·        Investigations

·        Reprocessing/Reworking

·        Packaging and Labeling