Effective GMP Auditing - Part Two Skills to Audit Manufacturing, Laboratories, and Suppliers
Conducted by David Inglis, PhD
Director of Ulverston GMP Consulting Ltd.
This series of FOUR one-hour web seminars is targeted at Quality Assurance auditors and production management responsible for leading and receiving internal audits (QA-led) and also for supplier auditing.
To be a business benefit rather than a drain on resources, your auditing programs must be integral to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements.
Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.
Session One - Organization of the Internal Audit Program
Session Two - What to Look For When Auditing Products Manufacturers
Session Three - What to Look For When Auditing API Manufacturers
Session Four - Supplier Audits - Responsibilities and Commitments of
Drug Product Manufacturers
Full descriptions of each program and Dr. Inglis' qualifications can be found below.
Simply scroll down.
Who should participate?
- QA auditors and trainees
- Production managers who receive internal QA and corporate GMP audits
- Engineering managers who receive internal QA and corporate GMP audits
- Production supervisors who lead Self Inspection audits
- Auditors of suppliers and contractors (both API and products)
These seminars will be conducted on the telephone and are presented by David Inglis, PhD, an industry expert on this and other compliance related topics. In this unique web seminar format, lasting just one hour each, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Inglis.
Session One - Organization of the Internal Audit Program
During this web seminar, we will look at a proven structure for internal QA-led audits (sometimes called Self Inspections). This session will also detail the necessary interaction between production/engineering management and the QA audit team to maximize the benefits and added value from the audit program.
Organization of the Internal Audit Program
Purpose of the QA Audit Program
- why is it necessary
- what value does it add?
Establishing the Audit Program
- What, where, and how often?
Setting up and training the Inspection Team
- who should be involved?
- what is expected of them?
Conducting and Reporting the Inspections
- conducting the inspection
- structure of the report
- completion and closure of actions
Session Two - What to Look For When Auditing Products Manufacturers
In this web seminar, we will address the key issues to investigate when auditing a manufacturer of drug products as a potential contractor. This session will give guidance on how to apply the principles of auditing, already established in the series, to specific areas of production, testing and record keeping. (Note that only the general issues of computer systems will be covered – this is not intended as detailed training on compliance with 21CFR Part 11 or Annex 11 of the EU Guide to GMP.)
What to Look For When Auditing Products Manufacturers
- Computer systems
- Oral solid and liquid dosage forms
- QC laboratories
- Packaging, labelling, and distribution
Session Three - What to Look For When Auditing API Manufacturers
In this webseminar, we will concentrate on the differences an auditor may expect to encounter when visiting an API production site, in comparison to a drug products site. The session is based on ICH Q7 (Part II of the EU Guide to GMP) and will discuss practical features of the Quality System and other systems on an API site which are in compliance with Q7 but which appear to differ from traditional compliance with drug products GMPs (e.g. 21CFR, Parts 210 and 211).
What to Look For When Auditing API Manufacturers
- Documentation and systems
- Facilities and support services
- Validation activities
- Materials and Production controls
- Calibration
- Testing laboratories (QA/QC)
- Packaging and labelling
- Storage and distribution
- Training and training records
Session Four - Supplier Audits - Responsibilities and Commitments of Drug Product Manufacturers
In this web seminar, we will concentrate of the role of auditing when developing, initiating and maintaining a contract API manufacturer/supplier. Auditing will be seen in the context of ensuring the API is manufactured according to GMP on an ongoing basis. For a long time, this has been a FDA requirement which has now also become an EU legal requirement. This session will approach the product manufacturer’s responsibilities from a perspective which will satisfy both FDA and EU requirements.
Responsibilities and Commitments of Drug Product Manufacturers
- Developing requirements
- Risk assessment
- Assessment of potential suppliers
- Resource and cost implications of supplier auditing
- Decision making and managing risks
- Developing contracts
- Maintenance/policing GMP compliance at the supplier site
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.
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| Get the MP3 audio file and handout GMP081022E - MP3 and Handout materials Effective GMP Auditing Course Part Two Price includes all HANDOUT MATERIALS and audio MP3 file. |
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Instructor
David Inglis, Ph.D.
DR DAVID INGLIS is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning/decontamination, especially in bulk intermediates and APIs. He has a higher degree (Ph.D.) in enzyme chemistry (affinity chromatography).
During more than three decades in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance. He successfully pioneered automated HPLC methods, and then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates in clinical trials and for medicinal products imported into the EU.
Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA Systems- based inspections. He has extensive experience of being the lead spokesman during major regulatory inspections.
Dr Inglis is a specialist in cGMP training and QA system improvement. His flagship improvement package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.
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