Biotechnology Training Kit - Top 10 training programs in one package

The lack of proper training has resulted in noncompliance with regulatory requirements in many companies. The biotech regulatory landscape is rapidly changing and evolving. Biotech Companies and their staff need ongoing training to gain practical knowledge and learn from real-life scenarios.

Regulatory compliance training is essential to avoid putting yourself in the penalty box. To build a compliance culture, your entire staff must understand compliance with the regulatory requirements. Companies that don’t invest in training will continue to struggle with the issue of compliance and will lack the confidence to survive a compliance audit.

Biotechnology compliance training helps companies and individuals maintain a competitive advantage, and match up to the industry dynamics and its underwriting technologies.

Help yourself and your organization to stay abreast of the compliance and skills required for performance by ordering this training kit today.

All Modules:

Module 1: Raw Materials in Pharma/Biotech Production
Module 2: Quality Risk Management Overview for Pharma, Biopharma and Combination Products
Module 3: Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Module 4: Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
Module 5: Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
Module 6: Steam Sterilization Microbiology and Autoclave Performance Qualification
Module 7: Quality Control for Microbiological Media and Reagents
Module 8: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Module 9: Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
Module 10: Introduction to Biotechnology Analytical Methods

Part 1 : Raw Materials in Pharma/Biotech Production
Instructor: Peggy Berry

Areas Covered in the Webinar:

• Selecting raw material suppliers
• Receipt, Testing and Storage of starting materials
• Control strategy
• Submission of information
• Life cycle management

Part 2 : Quality Risk Management Overview for Pharma, Biopharma and Combination Products
Instructor: Tanvir Mahmud

Areas Covered in the Webinar:

Quality Risk Management Overview

• Understanding Risk
• Definitions and Concepts ICH Q9 and ISO 14971
• Risk Assessment
• Risk Control
• Risk Communication
• Risk Review
• Example of Risk Management Methods and Tools
• Define Pharmaceutical Excipients

Part 3 : Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Instructor: Nanda Subbarao

Areas Covered in the Webinar:

• What is the purpose of a forced degradation study?
• What are the conditions to be used during well characterized protein forced degradation study?
• How to test for the degradants?
• Design of a compliance wcp stability study based on the forced degradation results.
• How to conduct a biologics stability study?
• Common mistakes during forced degradation studies

Part 4 : Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
Instructor: Jim Polarine

Areas Covered in the Webinar:

• Learn ways to review environmental monitoring data.
• Discuss case studies on excursion investigations.
• Learn how facility design, personnel practices and cleaning and disinfection effect excursion investigations.
• Discuss worst case events that can cause excursions

Part 5 : Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
Instructor: Barry A Friedman

Areas Covered in the Webinar:

• Review of the current testing requirements to include Low Endotoxin Recovery (LER)
• What happened to the old 87/91 LAL Guidance for Industry Document
• What has replaced it and why
• Common issues, misunderstandings and misinterpretations
• Determine who comprise the Agency Guidance team within this new proposed Guidance
• Documents supporting this new Guidance
• Sampling, storage, handling and pooling
• How does transition happen from one bacterial endotoxin test to another
• Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
• The FDA's expectation for screening of therapeutic products

Part 6 : Steam Sterilization Microbiology and Autoclave Performance Qualification
Instructor: Danielle DeLucy

Areas Covered in the Webinar:

• Definitions.
• IQ/OQ/PQ Requirements for Autoclave Validation
• Autoclave Monitoring Tests
• Biological Indicators - How and When to Use
• Verification vs. Revalidation

Part 7 : Quality Control for Microbiological Media and Reagents
Instructor: Michael Brodsky

Areas Covered in the Webinar:

• Control points
• Critical control points
• QC from purchase to disposal
• Sterility
• Productivity
• Selectivity

Part 8 : Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Instructor: Joy McElroy

Areas Covered in the Webinar:

• Mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• How the reporting process supports products in research, development, and the marketplace
• How documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final study report
• Assessing and writing to the audience to produce effective written correspondence
• How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
• Reviewing and revising documents
• Writing patterns and knowing the answers to your questions about the English language

Part 9 : Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
Instructor: Jim Polarine

Areas Covered in the Webinar:

• Review data from “real-world” examples.
• Learn how to develop solutions to your microbial control problems.
• This seminar focuses on both preventative measures and corrective actions.
• This session will be interactive with audience input.

Part 10 : Introduction to Biotechnology Analytical Methods
Instructor: Robert D Seltzer

Areas Covered in the Webinar:

• Assays for Total Protein.
• Reverse Phase and Size Exclusion High Performance Liquid Chromatography.
• Ion Exchange High Performance Liquid Chromatography.
• Reducing and Non-Reducing Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis.
• Peptide Mapping.
• Isoelectric Focusing.
• Matrix-Assisted Laser Desorption Time-of-Flight (MALDITOF) Mass Spectrometry.
• Adventitious Agent Prevention, Clearance, and Testing.
• Mycoplasma Test.
• Alpha-Interferon Antiviral Bioassay.
• DNA Restriction Mapping.
• Enzyme-Linked ImmunoSorbent Assay (ELISA).
• Western Blotting.
• Polymerase Chain Reaction.

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