5 and 6 November 2019

Pharmaceutical GMP Auditor Training

This two-day training course covers how to effectively plan, perform, report and follow-up pharmaceutical audits against a range of pharmaceutical standards, including GMP, API GMP, Excipient GMP.

BACKGROUND

This is a unique training course for pharmaceutical auditors who will audit against pharmaceutical Good Manufacturing Practice (GMP) and/ or audit suppliers to pharmaceutical manufacturing sites. The course trains auditors how to professionally plan, perform, report and follow-up internal and supplier audits and is presented in a pharmaceutical context throughout the whole course.
The course covers the requirements of European Union GMP (EU GMP) vol 4, including the requirements of ICH Q9 and 10 and how these are used as the main reference base when auditing pharmaceutical manufacturing sites. Also included in the course is an overview of key standards for suppliers to the pharmaceutical industry, including ISO 9001, Active Pharmaceutical Ingredient GMP (API GMP), Excipient GMP, Packaging Supplier Standards as well as Good Distribution Practice (GDP) and how these should be used when auditing suppliers.

TARGET AUDIENCE

This course is aimed at internal and supplier auditors along with key personnel involved in Quality Assurance and Quality Management Systems. The course will also benefit those involved in the purchasing of incoming materials and individuals who look after the whole supply chain. Additionally, the course is ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no formal auditor training.

PROGRAM

DAY ONE

Module 1: Quality Management Systems
The latest regulatory requirements on Quality Management Systems;
The structure and legal status of PICs Audit Guidelines in EU;
PIC’s Recommendations on the use of Risk based Planning;
Auditing the Warehouse, Production, Packaging and Laboratories;
Non-Compliance classification;
Auditing systems – Training, Internal Audits and Management Review;
Deviations handling/Risk Management;
Complaints, CAPAs handling;
Good Practices for Computerised systems in Regulatory GXP environments.

Module 2: Auditing
Preparation for GXP compliance auditing;
Reasons for first, second & third party audits;
How to plan, execute, report and close-out internal and external audits
Good auditing techniques;
Checklist construction;
Auditing for compliance to GMP;
How to conduct audits that promote increased process performance;
ISO 19011:2018 changes made to guidelines for quality and management systems auditing

Case study: Group exercise about Risk assessment on the Heparin Case to identify any potential corrective actions necessary in the audit procedure. Each of four Syndicate Groups will prepare a plan for one of the following;
GMP audit of Sterile Production
GMP audit of Packaging
GLP audit of Laboratory
GDP audit of distribution facility

DAY TWO

Module 3: Suppliers Auditing
Supplier standards – API GMP, Excipient GMP, Packaging Suppliers
Standards and Good Distribution Practice (GDP)
The evolving role of Quality Assurance
The enhanced role for Senior Management
ISO 9001, ICH Q8, 9 and 10 and their role
Using audits to promote continual improvement
Thinking beyond GMP and product quality
Organisational efficiency, effectiveness and continual improvement

Case study: To determine the principals for auditing a third-party supplier
Risk Assessment exercise on the Heparin Case
Each of four Syndicate Groups will prepare a plan for one of the following:
GMP audit of Active Pharmaceutical Ingredient (API) Manufacture:
GMP audit of Investigational Medical Product (IMP) manufacture
GLP audit of Laboratory
GDP audit of distribution facility

SPEAKER BIOGRAPHY:

John DR Jolley – BSc Pharm, FRPharmS, FCQI CQP RSC

John is founder of PharmaConsult Global Ltd who provides technical consultancy and bespoke Personal and Professional training solutions to Healthcare Organisations to all10 of the WHO healthcare Regions of the World.
He has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society, the Chartered Quality Institute and is a Liveryman with the Worshipful Society of Apothecaries. He has held positions in; Clinical Research, Product Registration, Manufacturing, Quality Assurance as a practicing Qualified Person (QP) , and was Technical Director of Boehringer Ingelheim UK for 15 years before coming to work on International consultancy.
Contact details: John.jolley@pharmaconsult.co.uk

Psychology of Auditing Workshop
7 November 2019

BACKGROUND

This workshop aims to enrich the knowledge of delegates with additional behavioral skills during the audit being audited or auditee. The workshop will demonstrate how important for the audit success is the body language, as well as the cultural differences and the emotional relations.

TARGET AUDIENCE

This workshop is designed for Qualified Persons and Responsible Pharmacists, Quality Assurance Experts, involved in auditing process.

PROGRAM

The Psychology of Auditing: The Auditor
The power of questions;
Body language;
Time management;
The Role of auditor’s emotions and moods on audit judgment;
The Effects of Multitasking on Auditors’ Judgment Quality;
Management of conflict of interests;
Paying attention to cultural differences;

The Psychology of Auditing: The Auditee

The Auditor- Auditee relationship;
The different perspective of the Auditee;
Dealing with a difficult auditor;
“Not to do” things.
Groups’ session: How to conduct a closing meeting

SPEAKER BIOGRAPHY:

Prof. Assena Stoimenova, MPharm., PhD, MPH, MPsych

Assena Stoimenova is a full professor at the Health Policy and Management Department in the Faculty of public health, Medical University-Sofia. Her research interests include quality management, pharmacoeconomics, pharmaceutical legislation, social pharmacy, postgraduate education of pharmacists and medicinal products and food supplements usage. Prof. Stoimenova is author and co-author of more than 100 articles in scientific journals in her areas of research interests. She is lead auditor for ISO 9001, specialized in health care (pharmaceutical manufacturers and wholesalers, CROs, hospitals etc.) As quality consultant, she developed more than 30 quality management systems in the area of pharmaceutical manufacturing and distribution of medicines. She served as Chairman of Quality Committee of Bulgarian Pharmaceutical Union (2007-2010) and as Vice President of Bulgarian Pharmaceutical Union (2010-2013). Besides her academic carrier, prof. Stoimenova gained more than 14 years’ experience in the pharmaceutical industry in the areas of quality management, regulatory affairs, marketing and drug safety. Former member of National Council of Pricing and Reimbursement – 2013-2014. Since Jul.2014 until Aug.2018 prof. Stoimenova served as an Executive Director of Bulgarian Drug Agency.
Contact details: assena_stoimenova@mail.bg

FEES (per person, VAT not included)

GMP Auditor Training
EARLYBIRD TICKET – 900 BGN (available until 05 September 2019)
REGULAR TICKET –1250 BGN
Bulgarian QP Association member – 1050 BGN
Two or more delegates from one organization – 1050 BGN/ per person

Psychology of Auditing Workshop
REGULAR TICKET –450 BGN

COMBINED TICKET
GMP Auditor Training + Psychology of Auditing
EARLYBIRD TICKET – 1250 BGN (available until 05 September 2019)
REGULAR TICKET – 1600 BGN
Bulgarian QP Association member – 1400 BGN
Two or more delegates from one organization – 1400 BGN/ per person
The seminar fee is payable in advance and includes training documentation, lunches and refreshments.

DATE

GMP Auditor Training
Tuesday, 05 November 2019
Registration and coffee 8:30 – 9:00h
First day sessions (9:00h -17:00h)
Wednesday, 06 November 2019 (9:00h – 17:00h)
Psychology of Auditing Workshop
Thursday, 07 November 2019 ( 9:00h – 17:00h )

REGISTRATION

Via the registration form
http://bit.ly/bgqpacom-2

VENUE

Hotel GRAMI
1712 Sofia, #79G Alexander Malinov blvd.
www.gramihotelsofia.com
reservations@gramihotelsofia.com
Phone  +359 2 4349111; +359 885 304 200; +359 2 4349115
BGQPA has reserved a limited number of rooms in the conference hotel. Reservation should be made directly with the hotel. Early reservation is recommended.

ORGANIZATION AND CONTACT

For questions please contact us:
bulgarian_qp_association@abv.bg
www.bgqpa.com
Mob +359886594949


DOWNLOAD the brochure in pdf